A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CC-99677 in Healthy Adult Subjects
NCT03554993 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2020-02-26
Summary
This is a phase 1, randomized, single-center, 3-part, FIH study to assess the safety, tolerability, pharmacokinetics (PK, or how the drug behaves in the body), and pharmacodynamics (PD, or what the drug does to the body) of single and multiple doses of CC-99677 and to characterize the effect of food on the single-dose PK of CC-99677 in healthy adult subjects.
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
CC-99677
CC-99677
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Francisco Ramirez-Valle, MD, PhD · Celgene
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-05-23
- Primary Completion
- 2019-07-03
- Completion
- 2019-07-03
Countries
- United Kingdom
Study Locations
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