Healthy volunteers (extinction of fear) MedDRA version: 19.0 Level: PT Classification code 10016275 Term: Fear System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Code: PF04457845
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Linköping University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >18 years, and willing to provide informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: None;Primary end point(s): Fear potentiated startle amplitude, measured by facial EMG (change from baseline) following completion of extinction training. ;Timepoint(s) of evaluation of this end point: Laboratory sessions carried out on day 9 and 10 of dosing the IMP or its placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The magnitude of affective response to stress challenge as measured by facial EMG and biochemical biomarkers.;Timepoint(s) of evaluation of this end point: Laboratory sessions carried out on day 9 and 10 of dosing the IMP or its placebo | — |
Countries
Sweden
Contacts
Public ContactLinköping Univ
Linköping Univ
Outcome results
None listed