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

NeRRe Therapeutics

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic Study in Healthy Male Volunteers

Treatments: Drug: Itraconazole; Drug: Orvepitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03535662

ORV-1-01

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Orvepitant

Experimental group

Description:

Orvepitant single 20mg dose

Treatment:

Drug: Orvepitant

Orvepitant and itraconazole

Experimental group

Description:

Orvepitant single 20mg dose in combination with repeat dose itraconazole

Treatment:

Drug: Itraconazole

Drug: Orvepitant