A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
88
Single dose of ACT-1014-6470; soft capsules for oral use.
Multiple doses of ACT-1014-6470; soft capsules for oral use.
Single dose of matching placebo; soft capsules for oral use.
PRA Health Sciences
Groningen, Netherlands
All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf)
Blood samples for determination of PK parameters will be collected at predefined time points from Day 1 to Day 4 of Part A (SAD, Day 1 to Day 8 for ADME cohort A4) and from Day 1 to Day X+3 of Part B (MAD, with Day X = day of last study treatment administration).
Time frame: Total duration of assessments: up to 3 weeks.
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Multiple doses of matching placebo; soft capsules for oral use.
Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.
Single dose of matching placebo; soft capsules for oral use.