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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03535662

Enrollment

Registered

2018-05-24

Start date

2018-06-08

Completion date

2018-08-09

Last updated

2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic Study in Healthy Male Volunteers

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.

Interventions

DRUGOrvepitant

Single oral dose

DRUGItraconazole

Once daily dosing for 10 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026