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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03535662
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Nerre Therapeutics Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pharmacokinetic Study in Healthy Male Volunteers Drug: Orvepitant Drug: Itraconazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : August 9, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Orvepitant
Orvepitant single 20mg dose
 Drug: Orvepitant
Single oral dose
Experimental: Orvepitant and itraconazole
Orvepitant single 20mg dose in combination with repeat dose itraconazole
 Drug: Orvepitant
Single oral dose

Drug: Itraconazole
Once daily dosing for 10 days


Outcome Measures
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Primary Outcome Measures :
  1. Exposure to orvepitant [ Time Frame: 0 to 168 hours post dose ]
    Area Under Curve (AUC)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535662


Locations
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United Kingdom
Parexel Epcu
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Nerre Therapeutics Ltd.
Investigators
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Principal Investigator: Principal Investigator PAREXEL EPCU
More Information
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Responsible Party: Nerre Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT03535662    
Other Study ID Numbers: ORV-1-01
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Itraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors