MedPath

Orvepitant

Generic Name
Orvepitant
Drug Type
Small Molecule
Chemical Formula
C31H35F7N4O2
CAS Number
579475-18-6
Unique Ingredient Identifier
IIU6V0W3JD
Background

Orvepitant has been used in trials studying the treatment of Depressive Disorder, Depressive Disorder, Major, Post-Traumatic Stress Disorder, and Posttraumatic Stress Disorder (PTSD).

Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

Phase 2
Completed
Conditions
Cough
Idiopathic Pulmonary Fibrosis
Interventions
First Posted Date
2022-01-11
Last Posted Date
2024-06-24
Lead Sponsor
Nerre Therapeutics Ltd.
Target Recruit Count
80
Registration Number
NCT05185089
Locations
🇺🇸

PulmonIx, LLC, Greensboro, North Carolina, United States

🇺🇸

Baylor University, Dallas, Texas, United States

🇺🇸

Jadestone Clinical Research, LLC, Silver Spring, Maryland, United States

and more 31 locations

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

Phase 1
Completed
Conditions
Pharmacokinetic Study in Healthy Male Volunteers
Interventions
First Posted Date
2018-05-24
Last Posted Date
2018-10-11
Lead Sponsor
Nerre Therapeutics Ltd.
Target Recruit Count
16
Registration Number
NCT03535662
Locations
🇬🇧

Parexel Epcu, Harrow, Middlesex, United Kingdom

A Study of the Efficacy and Safety of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis

Phase 2
Withdrawn
Conditions
Pruritus
Atopic Dermatitis
Interventions
Drug: Placebo
First Posted Date
2018-03-14
Last Posted Date
2018-05-15
Lead Sponsor
Nerre Therapeutics Ltd.
Registration Number
NCT03464526

A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

Phase 2
Completed
Conditions
Chronic Refractory Cough
Interventions
First Posted Date
2016-12-15
Last Posted Date
2022-04-26
Lead Sponsor
Nerre Therapeutics Ltd.
Target Recruit Count
315
Registration Number
NCT02993822
Locations
🇺🇸

Study Site 22, Dallas, Texas, United States

🇺🇸

Study Site 43, Los Angeles, California, United States

🇺🇸

Study Site 10, Houston, Texas, United States

and more 63 locations

Orvepitant (GW823296) in Adult Post Traumatic Stress Disorder

Phase 2
Completed
Conditions
Post-Traumatic Stress Disorder
Interventions
Other: Placebo
First Posted Date
2009-10-23
Last Posted Date
2017-09-01
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
132
Registration Number
NCT01000493
Locations
🇺🇸

GSK Investigational Site, Middleton, Wisconsin, United States

A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder

Phase 2
Terminated
Conditions
Depressive Disorder
Interventions
Other: Placebo
First Posted Date
2009-04-13
Last Posted Date
2017-10-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
343
Registration Number
NCT00880048
Locations
🇨🇦

GSK Investigational Site, Gatineau, Quebec, Canada

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed Dose Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder

Phase 2
Terminated
Conditions
Depressive Disorder, Major
Interventions
Other: placebo
First Posted Date
2009-04-13
Last Posted Date
2017-09-12
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
328
Registration Number
NCT00880399
Locations
🇨🇦

GSK Investigational Site, Toronto, Ontario, Canada

Food and Relative Bioavailability Study

Phase 1
Completed
Conditions
Depressive Disorder
Interventions
First Posted Date
2009-02-13
Last Posted Date
2017-07-21
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
14
Registration Number
NCT00843011
Locations
🇮🇹

GSK Investigational Site, Verona, Veneto, Italy

GW823296 Repeat Dose Study In Healthy Male And Female Subjects

Phase 1
Completed
Conditions
Healthy Subjects
First Posted Date
2008-05-08
Last Posted Date
2010-10-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
30
Registration Number
NCT00675116
Locations
🇦🇺

GSK Investigational Site, Adelaide, South Australia, Australia

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