E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (extinction of fear) |
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E.1.1.1 | Medical condition in easily understood language |
Unlearning of fear memories in healthy volunteers |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016275 |
E.1.2 | Term | Fear |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 evaluate the ability of the fatty acid amide hydrolase (FAAH) inhibitor PF-04457845 to potentiate extinction of fear memories using a laboratory paradigm in healthy volunteers. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age >18 years, and willing to provide informed consent. |
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E.4 | Principal exclusion criteria |
Lifetime diagnosis of psychosis or bipolar disease, current axis 1 diagnosis; as determined by a history, clinical examination and MINI interview carried out by appropriately trained staff
Ongoing (within the last month) psychiatric medication
Current (within the last month) use of illicit drugs, as identified using the Drug Use Disorder Identification Test (DUDIT).
Co-medication with CYP3A inhibitors, CYP3A inducers or P-glycoprotein substrates.
Any other current medication or medical condition that in the judgment of the investigator could interfere with treatment.
Pregnancy or nursing. To be eligible, women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test prior to the start of study drug. WOCBP and males with WOCBP partners must agree to use a method of contraception that is highly effective for the duration of the study and for at least 28 days after the intake of the study drug. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Clinically significant deviations from normal range of physiological functions as determined by a specialist consult when needed (blood pressure, heart rate, AST, ALT, GGT, WBC with differential, Hb, MCV, TPK, LPK and CRP).
Due to the nature of the tasks, we will also exclude anyone with hearing impairments.
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E.5 End points |
E.5.1 | Primary end point(s) |
Fear potentiated startle amplitude, measured by facial EMG (change from baseline) following completion of extinction training. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Laboratory sessions carried out on day 9 and 10 of dosing the IMP or its placebo |
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E.5.2 | Secondary end point(s) |
The magnitude of affective response to stress challenge as measured by facial EMG and biochemical biomarkers. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Laboratory sessions carried out on day 9 and 10 of dosing the IMP or its placebo |
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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 | No |
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 |
To investigate basic neural mechanisms of fear learning |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |