64
Participants
Start Date
March 25, 2019
Primary Completion Date
July 11, 2019
Study Completion Date
July 11, 2019
ACT-1004-1239
ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg. For the ADME subpart, a single oral dose of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given simultaneously with the ACT-1004-1239 capsule. For the absolute bioavailability subpart, a single intravenous dose of a maximum of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given at the expected tmax after the administration of the ACT-1004-1239 capsule.
Placebo
Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
ACT-1004-1239 (Food-effect subpart)
ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg.
Placebo (Food-effect subpart)
Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
Pharmaron CPC, Inc. & Affiliates, Baltimore
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
INDUSTRY