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NCT03535662
A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers
Phase 1 trial testing Orvepitant in Pharmacokinetic Study in Healthy Male Volunteers in 16 participants. Completed in 9 August 2018.
9 August 2018
Quick facts
| Lead sponsor | Nerre Therapeutics Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 8 June 2018 |
| Primary completion | 9 August 2018 |
| Estimated completion | 9 August 2018 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Orvepitant — full drug profile →
- Itraconazole — full drug profile →
Conditions studied
- Pharmacokinetic Study in Healthy Male Volunteers — all drugs for Pharmacokinetic Study in Healthy Male Volunteers →
Sponsor
Nerre Therapeutics Ltd. — full company profile →
Who can join
Adults 18 to 45, male only, with Pharmacokinetic Study in Healthy Male Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03535662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Orvepitant
Trials testing the same drug.
- NCT00843011 — Food and Relative Bioavailability Study · Phase 1 · completed
Other Nerre Therapeutics Ltd. trials
Trials by the same sponsor.
- NCT05185089 — Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis · Phase 2 · completed
- NCT04387981 — Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects · Phase 1 · completed
- NCT02993822 — A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03535662 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nerre Therapeutics Ltd.
- Last refreshed: 11 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03535662.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing