Last updated: 11/07/2018 14:38:00
An Evaluation of the Safety, Tolerability, Pharmacokinetics and Protein Binding of BRL 49653C in Patients with Hepatic Impairment
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Evaluation of the Safety, Tolerability, Pharmacokinetics and Protein Binding of BRL 49653C in Patients with Hepatic Impairment
Trial description: An Evaluation of the Safety, Tolerability, Pharmacokinetics and Protein Binding of BRL 49653C in Patients with Hepatic Impairment
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Effect of Hepatic Impairment on the Pharmacokinectics (PK) of Rosiglitazone (RSG), Miller, A K, MD; Inglis, A L, MD; Thompson, K, MD; Davie, C C, MD; Schenker, S, MD; Blum, R, MD; Jorkasky, D, MD; Freed, M I, MD. Texas Health Science Center, San Antonio, Texas; DMPK, United Kingdom; San Antonio, TX; USA. 100th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics. 3/18/1999
Abstract: Peroxisome Proliferator-Activated Receptor gamma (PPARg) Modulation of Cytokine-Mediated Suppression of Hepatic Mrp3 Gene Expression, Miller, Bob; Zimmerman, Tracy; Mulder, Jaap; Ghose, Romi; Washington, DC; USA. 115th Annual Meeting of the American Pediatric Society and 74th Annual Meeting of the Society for Pediatric Research together with the American Society of Pediatric Hematology/Oncology, the American Society of Pediatric Nephrology, the Lawson Wilkins Pediatric Endocrine Society and the Pediatric Infectious Disease Society. 5/14/2005
Miller AK, Inglis AL, Thompson K, Davie CC, Schenker S, Blum R, Jorkasky D, Freed MI. Effect of hepatic impairment on the pharmacokinetics (PK) of rosiglitazone (RSG). Clin Pharmacol Ther 1999; 65: 186. Clin Pharmacol Ther 1999; 65: 186 PIII-37 presented at ASCPT 1999.
Medical condition
Diabetes Mellitus
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
May 1997 to December 1997
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1997-15-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website