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

NCT03535662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-10-11

No results posted yet for this study

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

Interventions

DRUG

Orvepitant

Single oral dose

DRUG

Itraconazole

Once daily dosing for 10 days

Sponsors & Collaborators

  • Nerre Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · PAREXEL EPCU

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2018-08-09
Completion
2018-08-09
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535662 on ClinicalTrials.gov