E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C virus (HCV) infection |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the bioavailability of the experimental GLE + PIB
pediatric formulation relative to the reference Phase 3 adult formulation under fasting and non-fasting conditions.
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E.2.2 | Secondary objectives of the trial |
To assess the effect of high-fat and low-fat meals on the experimental
GLE + PIB pediatric formulation relative to fasting conditions.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female between 18 and 55 years of age inclusive at the time of screening.
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 × the upper limit of normal (ULN) at Screening visit and Period 1 Day –1
- Negative test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), HCV antibody (Ab) and human immunodeficiency virus (HIV) Ab at Screening visit
- No clinically significant ECG abnormalities
- Subjects must not have been treated with any investigational drug within 6 weeks or within a period defined by 5 half-lives, whichever is longer, prior to the first dose of study drug.
- Subject must not have received any live vaccine within 4 weeks prior to the first dose of study drug, or has an expected need of live vaccination during study participation including at least 4 weeks after the last dose of study drug.
- Subject must not require any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, on a regular basis. |
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E.4 | Principal exclusion criteria |
- Subjects who are not between 18 and 55 years of age
- Body Mass Index (BMI) is outside of the following range: 18.0 to 29.9 kg/m2
- Positive test for hepatitis A virus immunoglobulin M (HAV-IgM)
- Significant ECG abnormalities
- Subjects have been treated with an investigation drug within 6 weeks or within a period defined by 5 half-lives, whichever is longer, prior to the first dose of study drug.
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) at abnormal levels at Screening visit and Period 1 Day –1
- Subject have received any live vaccine within 4 weeks prior to the first dose of study drug, or has an expected need of live vaccination during study participation including at least 4 weeks after the last dose of study drug.
- Subject requires any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, on a regular basis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety evaluations include adverse event (AE) monitoring, physical examinations, vital sign measurements, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The values for the pharmacokinetic parameters of GLE and PIB including the maximum observed plasma concentration (Cmax), the time to Cmax(Tmax), apparent terminal phase elimination rate constant (β), terminal phase elimination half-life (t1/2), the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) and from time 0 to infinity (AUCinf) will be determined using non-compartmental methods. Additional parameters may be estimated if useful in the interpretation of the data. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Part1: Four sequence, four period Part2: three sequence, three period study design |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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
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The end-of-study is defined as the date of the last subject's last visit.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |