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

NCT03535662 | Completed Phase 1 FDA Drug

• 1 other identifier: ORV-1-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetic Study in Healthy Male Volunteers

Outcome Measures

Primary Outcomes (1)

• Exposure to orvepitant

  Area Under Curve (AUC)

  0 to 168 hours post dose

Study Arms (2)

Orvepitant

EXPERIMENTAL

Orvepitant single 20mg dose

Drug: Orvepitant

Orvepitant and itraconazole

EXPERIMENTAL

Orvepitant single 20mg dose in combination with repeat dose itraconazole

Drug: Orvepitant; Drug: Itraconazole

Interventions

Orvepitant DRUG

Single oral dose

Orvepitant; Orvepitant and itraconazole

Itraconazole DRUG

Once daily dosing for 10 days

Orvepitant and itraconazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nerre Therapeutics Ltd.: lead

Study Sites (1)

Parexel Epcu

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

orvepitant; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Principal Investigator

  PAREXEL EPCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 24, 2018
• Study Start: June 8, 2018
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)