A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
Public ClinicalTrials.gov record NCT03290443. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 1, Open-Label Single-Dose Study to Assess the Pharmacokinetics of Enasidenib (AG 221, CC 90007) in Subjects With Moderate and Severe Hepatic Impairment.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease
Study identification
- NCT ID
- NCT03290443
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 31 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 21, 2017 (Actual)
- Primary completion
- Oct 26, 2018 (Actual)
- Completion
- Oct 26, 2018 (Actual)
- Last update posted
- Jul 17, 2020
2017 – 2018
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| DaVita Clinical Research | Lakewood | Colorado | 80228 | — |
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014-3616 | — |
| Orlando Clinical Research Center OCRC | Orlando | Florida | 32809 | — |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | — |
| New Orleans Center of Clinical Research | Knoxville | Tennessee | 37920 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03290443, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2020 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03290443 live on ClinicalTrials.gov.