This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
64
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.
Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without 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.
Pharmaron CPC, Inc. & Affiliates
Baltimore, Maryland, United States
Number of patients with treatment-emergent (serious) adverse events (AEs and SAEs)
Time frame: From baseline up to EOS of each cohort (total duration: up to 6 weeks)
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Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.