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NCT03209648
A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects
Phase 1 trial testing Debio 1450 in Healthy Participants in 20 participants. Completed in 31 August 2017.
23 August 2017
Quick facts
| Lead sponsor | Debiopharm International SA |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 14 June 2017 |
| Primary completion | 23 August 2017 |
| Estimated completion | 31 August 2017 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Debio 1450
- Itraconazole — full drug profile →
Conditions studied
- Healthy Participants — all drugs for Healthy Participants →
Sponsor
Debiopharm International SA — full company profile →
Who can join
Adults 18 to 60, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.
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 NCT03209648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Debiopharm International SA trials
Trials by the same sponsor.
- NCT05147350 — Study of RP-6306 With FOLFIRI in Advanced Solid Tumors · Phase 1 · terminated
- NCT05364944 — A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Ac · Phase 1 · terminated
- NCT05147272 — Study of RP-6306 With Gemcitabine in Advanced Solid Tumors · Phase 1 · terminated
- NCT04962724 — A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male · Phase 1 · completed
- NCT03968653 — Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors · Phase 1 · terminated
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 NCT03209648 (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 Debiopharm International SA
- Last refreshed: 18 October 2017
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/NCT03209648.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing