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OpenTrials
Completed

NCT Number: NCT03535662

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

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.

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Key information

Conditions

Pharmacokinetic Study in Healthy Male Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Epcu

Harrow, Middlesex, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orvepitant

Drug

Single oral dose

Itraconazole

Drug

Once daily dosing for 10 days

Primary outcomes

  1. Exposure to orvepitant

    Time frame: 0 to 168 hours post dose

    Area Under Curve (AUC)

Sponsors and collaborators

Lead sponsor

Nerre Therapeutics Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 24, 2018
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.