common.study.topics.clinical

Testing Experimental Medication in Healthy Subjects

common.study.values.description

A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects

This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects. The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Drug - CC-90001

CC-90001

participant.views.study.view.additional

participant.views.study.view.scientific-title

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety/Tolerability of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects

common.study.values.clinical-trial-id

NCT03958864

participant.views.study.view.id

bo2lYa