Trials / Completed
CompletedNCT03865446
Evaluate Severe Hepatic Impairment on Dacomitinib PK
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS AND SAFETY OF DACOMITINIB IN PARTICIPANTS WITH SEVERELY IMPAIRED HEPATIC FUNCTION RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
Detailed description
This is a Phase 1, open label, parallel group study to investigate the effect of severe hepatic impairment on the plasma PK, safety and tolerability after a single oral 30 mg dose of dacomitinib under fasted conditions. Approximately 18 participants will be enrolled into the study to ensure at least 6 PK evaluable (having data for estimating primary PK parameters for dacomitinib) participants in each cohort.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dacomitinib | anti-cancer agent |
Timeline
- Start date
- 2019-04-05
- Primary completion
- 2019-10-24
- Completion
- 2019-10-24
- First posted
- 2019-03-06
- Last updated
- 2020-11-06
- Results posted
- 2020-11-06
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03865446. Inclusion in this directory is not an endorsement.