Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
NCT04060147 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2023-07-27
Summary
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
Conditions
- Primary Sclerosing Cholangitis
- Compensated Cirrhosis
Interventions
- DRUG
-
Cilofexor
Tablets administered orally once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-17
- Primary Completion
- 2021-09-02
- Completion
- 2021-09-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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