A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
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|ClinicalTrials.gov Identifier: NCT03290443|
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : July 4, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Impairment||Drug: Enasidenib||Phase 1|
Subjects will be enrolled in Groups 1 through 4 as follows:
- Group 1: Approximately 6 to 8 male and female subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 1.
- Group 2: Approximately 6 to 8 healthy male and female subjects with normal hepatic function will be enrolled in Group 2. Subjects in Group 2 will be matched to subjects in Group 1 with respect to sex, age (± 10 years), and weight (± 30 pounds).
- Group 3: Approximately 6 to 8 male and female subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 3.
- Group 4: Approximately 6 to 8 healthy male and female subjects with normal hepatic function will be enrolled in Group 4. Subjects in Group 4 will be matched to subjects in Group 3 with respect to sex, age (± 10 years), and weight (± 30 pounds). This study employs a staged design as follows.
- At least 4 subjects with moderate hepatic impairment must demonstrate satisfactory safety and tolerability for up to 8 days after dosing, before subjects with severe hepatic impairment may be dosed.
- Two subjects with severe hepatic impairment must demonstrate satisfactory safety and tolerability for up to 8 days after dosing, before the remaining subjects with severe hepatic impairment may be dosed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||September 21, 2017|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2018|
Experimental: Enasidenib (CC-90007) tablet
Subjects will receive one 100 mg enasidenib (CC-90007) tablet the morning of Day 1 which will be administered in the fasted state.
100 mg enasidenib (CC-90007)
- Pharmacokinetics - Cmax [ Time Frame: Day 1 ]Estimation of maximum observed plasma concentration
- Pharmacokinetics - AUC0-∞ [ Time Frame: Up to Day 36 ]Estimation of AUC from time zero extrapolated to infinity
- Pharmacokinetics - AUC0-t [ Time Frame: Up to Day 36 ]Estimation of AUC from time zero extrapolated to last time point
- Pharmacokinetics - tmax [ Time Frame: Day 1 ]Time to reach Cmax
- Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]Number of participants with adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290443
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|United States, Colorado|
|DaVita Clinical Research||Completed|
|Lakewood, Colorado, United States, 80228|
|United States, Florida|
|Clinical Pharmacology of Miami, LLC||Not yet recruiting|
|Miami, Florida, United States, 33014-3616|
|Orlando Clinical Research Center OCRC||Not yet recruiting|
|Orlando, Florida, United States, 32809|
|United States, Minnesota|
|DaVita Clinical Research||Completed|
|Minneapolis, Minnesota, United States, 55404|
|United States, Tennessee|
|New Orleans Center of Clinical Research||Recruiting|
|Knoxville, Tennessee, United States, 37920|
|Study Director:||Leon Carayannopoulos, MD||Celgene|