A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
NCT ID: NCT04183686
Last Updated: 2020-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
88 participants
INTERVENTIONAL
2019-11-25
2020-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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Part A (SAD): Dose A1
Single dose A1 of ACT-1014-6470; soft capsule for oral use.
ACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
Part A (SAD): Dose A2
Single dose A2 of ACT-1014-6470; soft capsule for oral use.
ACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
Part A (SAD): Dose A3
Single dose A3 of ACT-1014-6470 under fasted and fed conditions, separated by at least 18 days; soft capsule for oral use.
ACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
Part A (SAD): Dose A4
Single dose A4 of ACT-1014-6470; soft capsule for oral use.
ACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
14C-ACT-1014-6470 microtracer
Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.
14C-ACT-1014-6470 microtracer placebo
Single dose of matching placebo; soft capsules for oral use.
Part A (SAD): Dose A5
Single dose A5 of ACT-1014-6470; soft capsule for oral use.
ACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
Part A (SAD): Dose A6
Single dose A6 of ACT-1014-6470; soft capsule for oral use.
ACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
Part B (MAD): Dose B1
Multiple doses B1 of ACT-1014-6470; soft capsules for oral use.
ACT-1014-6470 (MAD)
Multiple doses of ACT-1014-6470; soft capsules for oral use.
Placebo (MAD)
Multiple doses of matching placebo; soft capsules for oral use.
Part B (MAD): Dose B2
Multiple doses B2 of ACT-1014-6470; soft capsules for oral use.
ACT-1014-6470 (MAD)
Multiple doses of ACT-1014-6470; soft capsules for oral use.
Placebo (MAD)
Multiple doses of matching placebo; soft capsules for oral use.
Part B (MAD): Dose B3
Multiple doses B3 of ACT-1014-6470; soft capsules for oral use.
ACT-1014-6470 (MAD)
Multiple doses of ACT-1014-6470; soft capsules for oral use.
Placebo (MAD)
Multiple doses of matching placebo; soft capsules for oral use.
Part B (MAD): Dose B4
Multiple doses B4 of ACT-1014-6470; soft capsules for oral use.
ACT-1014-6470 (MAD)
Multiple doses of ACT-1014-6470; soft capsules for oral use.
Placebo (MAD)
Multiple doses of matching placebo; soft capsules for oral use.
Interventions
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ACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
ACT-1014-6470 (MAD)
Multiple doses of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
Placebo (MAD)
Multiple doses of matching placebo; soft capsules for oral use.
14C-ACT-1014-6470 microtracer
Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.
14C-ACT-1014-6470 microtracer placebo
Single dose of matching placebo; soft capsules for oral use.
Eligibility Criteria
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Inclusion Criteria
* Healthy male (Part A and B) and female subjects (Part B) aged between 18 and 55 years (inclusive) at Screening.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
* Male subjects with a partner who might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use a highly effective method of contraception.
* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a highly effective method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner.
* Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
Exclusion Criteria
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
* Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed workers, as defined in the relevant Ionising Radiation Regulations, must not participate in the study.
* Participation in any study involving administration of any 14C radiolabeled compound within the 12 months prior to Screening.
\- Pregnant or lactating women.
18 Years
55 Years
ALL
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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PRA Health Sciences
Groningen, , Netherlands
Countries
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Other Identifiers
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ID-087-101
Identifier Type: -
Identifier Source: org_study_id
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