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NCT02873650
Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment
Phase 1 trial testing dabrafenib in Hepatic Impairment in 5 participants. Terminated before completion.
12 October 2018
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 5 |
| Start date | 20 December 2016 |
| Primary completion | 12 October 2018 |
| Estimated completion | 8 April 2019 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- dabrafenib (dabrafenib) — full drug profile →
Conditions studied
- Hepatic Impairment — all drugs for Hepatic Impairment →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02873650
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of dabrafenib
Trials testing the same drug.
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- NCT04666272 — Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With St · active not recruiting
- NCT03975829 — Pediatric Long-Term Follow-up and Rollover Study · Phase 4 · active not recruiting
- NCT03553329 — Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti B · completed
Other recruiting trials for Hepatic Impairment
Currently open trials in the same condition.
- NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
- NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
- NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
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 NCT02873650 (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 Novartis Pharmaceuticals
- Last refreshed: 8 December 2020
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/NCT02873650.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing