Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406

Phase 1 Completed 90 enrolled Gilead Sciences

RandomizedSequentialQuadruple-blindTreatment

Summary

The study is designed as a single center, randomized, double-blind, placebo-controlled study to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study will be conducted as a 2-part study.

Timeline

Start: 2020-07-07
Primary completion: 2021-05-30
Completion: 2021-06-06

Publications

Background Aronow WS, Harding PR, Khursheed M, Vangrow JS, Papageorge's NP, Mays J. Effect of halofenate on serum lipids. Clin Pharmacol Ther. 1973 May-Jun;14(3):358-65. doi: 10.1002/cpt1973143358. No abstract available.
Background Dujovne CA, Azarnoff DL, Pentikainen P, Manion C, Hurwitz A, Hassanein K. A two-year crossover therapeutic trial with halofenate and clofibrate. Am J Med Sci. 1976 Nov-Dec;272(3):277-84. doi: 10.1097/00000441-197611000-00005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CB-0406	Unknown	100 mg	Oral
Subject	CB-0406	Unknown	200 mg	Oral
Subject	CB-0406	Unknown	400 mg	Oral
Subject	CB-0406	Unknown	800 mg	Oral
Subject	CB-0406	Unknown	1000 mg	Oral

Indications

No indication recorded.