Clinical Trials Register

Summary
EudraCT Number:	2010-020832-20
Sponsor's Protocol Code Number:	P06356
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-07-29
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2010-020832-20

A.3

Full title of the trial

An Evaluation of the Safety and Pharmacokinetics of Posaconazole (POS, SCH 56592) IV Solution via Peripheral Administration in Healthy Volunteers (P06356)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

P06356

A.3.2

Name or abbreviated title of the trial where available

Safety and Pharmacokinetics of POS IV Solution via Peripheral Administration in Healthy Volunteers

A.4.1

Sponsor's protocol code number

P06356

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Schering-Plough Research Institute, a Division of Schering Corporation - for Global trials
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Schering-Plough Research Institute
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	QPS Netherlands B.V. (Xendo)
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Petrus Campersingel 123
B.5.3.2	Town/ city	Groningen
B.5.3.3	Post code	9713 AG
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	3150368 1033
B.5.5	Fax number	3150304 8001
B.5.6	E-mail	arjen.beynon@qps.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	SCH 56592 (POSACONAZOLE) Solution for Injection, 18 mg/mL
D.3.2	Product code	SCH 56592
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Posaconazole
D.3.9.1	CAS number	171228-49-2
D.3.9.2	Current sponsor code	SCH 56592
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	18
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

This study is going to be conducted in heathy volunteers.

E.1.1.1

Medical condition in easily understood language

Posaconazole IV solution is a drug that is being developed for the treatment of fungal infections

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate safety and tolerability of posaconazole (POS) IV Solution as single dose via peripheral infusion.

E.2.2

Secondary objectives of the trial

Obtain PK and metabolite profiles of POS IV Solution.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

2. Subjects of either sex and of any race between the ages of 18 and 65 years, inclusive, having a Body Mass Index (BMI) between 19 to 35, inclusive. BMI = weight (kg)/height (m2).
3. Subjects’ clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator. Subject’s liver function test results (ie, AST, ALT, and GGT) must not be elevated above the normal limits at Screening and on Day -1.
4. Subjects must be free of any clinically significant disease, especially onychomycosis that would interfere with the study evaluations.
5. Subjects must have suitable veins for cannulation and no previous thrombophlebitis.
6. Screening ECG conduction intervals must be within gender specific normal range (QTc males 430 msec and females 450 msec).
7. Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges:
a. systolic blood pressure, 90 to 140 mm Hg
b. diastolic blood pressure, 45 to 90 mm Hg
c. pulse rate, 40 to 100 bpm
8. Female subjects must be:
a. postmenopausal (defined as 12 months with no menses and with a FSH level of >35 u/L), and/or
b. surgically sterilized (eg, documented hysterectomy or tubal ligation)
Female subjects who are premenopausal and unsterilized must:
a. have used a medically accepted method of contraception for 2 months (or abstained from sexual intercourse) prior to the screening period. An acceptable method of contraception includes one of the following:
i. stable oral/transdermal/injectable hormonal contraceptive regimen without breakthrough uterine bleeding for 2 months prior to Screening visit and a condom with spermicide.
ii. intrauterine device (inserted at least 2 months prior to Screening visit) used with spermicide.
iii. condom (male or female) with spermicide,
iv. diaphragm or cervical cap with spermicide and condom,
Note: Vasectomy of the partner is not considered sufficient contraception and one of the 4 bulleted methods listed above must be used in conjunction with a condom (male or female) with spermicide, or diaphragm (or cervical cap).
b. agree to use one of the accepted methods of contraception (listed above) during the trial (including the screening period prior to receiving trial medication), and for 2 months after stopping the trial medication. Females who are not currently sexually active must also consent to use one of these accepted methods of contraception should they become sexually active while participating in the study.
9. Men must agree to use a medically accepted method of contraception (see Section 7.3.1.7 above), or abstain from sexual intercourse, during the trial and for 1 month after stopping the medication.

E.4

Principal exclusion criteria

1. Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating.
2. Anyone with a fungal infection that has occurred within 3 months of study start.
3. Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study (e.g., potassium, magnesium and calcium levels > 10% of their normal ranges).
4. Subjects who have been diagnosed with or suspect to have cardiomyopathy, or have a history of any types of heart diseases.
5. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following and be discussed with the sponsor prior to enrollment into the trial:
a. history or presence of liver disease or liver injury;
b. history or presence of impaired renal function as indicated by abnormal creatinine, urinary albumin, BUN/urea or clinical significant urinary cellular constituents (eg, cast); or
c. history of urinary obstruction or difficulty in voiding.
6. Subject who has a history of any clinically significant infectious disease within 4 weeks prior to drug administration.
7. Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
8. Subjects who have a positive screen for drugs and alcohol with a high potential for abuse.
9. Subjects with a history of mental instability or who have been treated for mood disorders.
10. Subjects with a history of alcohol or drug abuse in the past 2 years.
11. Subjects who have donated blood in the past 60 days prior to frist dosing.
12. Subjects who have previously received this compound.
13. Subjects who are currently participating in another clinical study or have participated in a clinical study within 90 days prior to 1st dosing.
14. Subjects who are part of the study staff personnel or family members of the study staff personnel.
15. Subjects who have demonstrated clinically significant allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes).
16. Subjects who smoke more than 10 cigarettes or equivalent tobacco use per day or more than 21 units of alcohol per week or 2 units of caffeine per day..
17. Subjects who have received any treatment listed in Table 2 more recently than the indicated washout period prior to Baseline.
18. Subjects on any steroid treatment.
19. Subjects with an abnormal ACTH stimulation test on Day -2 (cortisol <550 nmol/L or <21 µg/dL (Part 2 only).
20. Subject with predose left ventricular EF < 50%.

E.5 End points

E.5.1

Primary end point(s)

Safety and tolerability

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

PK profiles

E.5.2.1

Timepoint(s) of evaluation of this end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

0.9% NaCl

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last subject last visit or meet the study specified stopping criteria.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Any subject who does not complete the study is required to have a follow up visit.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-08-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-05-23

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