NCT02852239 is a Phase 1 clinical trial of dabrafenib in Renal Impairment, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02852239?

NCT02852239 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02852239?

Interventions in NCT02852239: dabrafenib.

What condition does NCT02852239 study?

NCT02852239 studies Renal Impairment.

Is NCT02852239 still recruiting?

NCT02852239 is currently completed. Last updated 9 December 2020.

Last reviewed 2020-12-09 · How we verify

NCT02852239

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment

Completed Phase 1 Last updated 9 December 2020

What this trial tests

Phase 1 trial testing dabrafenib in Renal Impairment in 22 participants. Completed in 27 September 2019.

Timeline

19 December 2016

Primary endpoint
27 September 2019

27 September 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	22
Start date	19 December 2016
Primary completion	27 September 2019
Estimated completion	27 September 2019
Sites	3 locations across United States

Drugs / interventions tested

dabrafenib (dabrafenib) — full drug profile →

Conditions studied

Renal Impairment — all drugs for Renal Impairment →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Renal 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 severe renal impairment and end stage renal disease not on dialysis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Reviewing the role of healthy volunteer studies in drug development.
Karakunnel JJ, Bui N, Palaniappan L, Schmidt KT, et al · · 2018 · cited 33× · PMID 30509294 · DOI 10.1186/s12967-018-1710-5

Verify or expand the search:

Other trials of dabrafenib

Trials testing the same drug.

NCT04961619 — Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma. · completed
NCT05299580 — "Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II · Phase 2 · withdrawn
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 Renal Impairment

Currently open trials in the same condition.

NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02852239 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 9 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/NCT02852239.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing