A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers
Phase 1
Completed
- Conditions
- Pharmacokinetic Study in Healthy Male Volunteers
- Interventions
- Registration Number
- NCT03535662
- Lead Sponsor
- Nerre Therapeutics Ltd.
- Brief Summary
A Phase 1 study to assess the effect of itraconazole, a strong inhibitor of CYP3A and P-glycoprotein, on the pharmacokinetics (PK) of orvepitant in healthy male volunteers.
Subjects will receive two single doses of 20mg orvepitant, once alone and once in combination with repeat doses of itraconazole. All subjects will follow the same sequence - orvepitant alone followed by orvepitant in combination with itraconazole.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- male volunteers
- judged to be in good health, based on the results of medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory findings
- body weight greater than 50 kg and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)
Key
Exclusion Criteria
- clinically significant findings on physical examination
- relevant medical history
- history of or considered at high risk of seizures (except febrile fits in childhood), including history of significant head injury
- positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or human immunodeficiency virus (HIV)
- serum biochemistry and full blood count considered by the Investigator to be of clinical significance
- systolic blood pressure <100 or >140 mmHg or diastolic BP <50 or ˃90 mmHg, measured prior to the first dose of orvepitant
- abnormal 12 lead electrocardiogram (ECG)
- has donated one or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study intervention administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Orvepitant and itraconazole Itraconazole Orvepitant single 20mg dose in combination with repeat dose itraconazole Orvepitant Orvepitant Orvepitant single 20mg dose Orvepitant and itraconazole Orvepitant Orvepitant single 20mg dose in combination with repeat dose itraconazole
- Primary Outcome Measures
Name Time Method Exposure to orvepitant 0 to 168 hours post dose Area Under Curve (AUC)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Parexel Epcu
🇬🇧Harrow, Middlesex, United Kingdom