A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers

Pharmacokinetic Study in Healthy Male Volunteers Clinical Trial

Official title:

A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Male Participants to Determine the Effect of an Inhibitor of Cytochrome P450 3A and P Glycoprotein on Exposure to Orvepitant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535662
• Other study ID #: ORV-1-01
• Status: Completed
• Phase: Phase 1
• Start date: June 8, 2018
• Est. completion date: August 9, 2018

Study information

• Verified date: October 2018
• Source: Nerre Therapeutics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 9, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Key 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

Related Conditions & MeSH terms

• Pharmacokinetic Study in Healthy Male Volunteers

Intervention

Drug:
• Orvepitant
Single oral dose
• Itraconazole
Once daily dosing for 10 days

Locations

Country	Name	City	State
United Kingdom	Parexel Epcu	Harrow	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Nerre Therapeutics Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to orvepitant	Area Under Curve (AUC)	0 to 168 hours post dose