Status:
COMPLETED
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects.
Eligibility Criteria
Inclusion
- General
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- 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.
- Inclusion Criteria for Part B:
- 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 less than 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.
- General
Exclusion
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- 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.
- Exclusion Criteria for the absorption,distribution, metabolism and excretion (ADME) evaluation:
- Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 milli sievert (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 Carbon-14 (14C) radiolabeled compound within the 12 months prior to Screening.
- Exclusion Criteria for Part B:
- Pregnant or lactating women.
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04798209
Start Date
January 29 2021
End Date
May 21 2022
Last Update
June 21 2022
Active Locations (1)
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1
QPS Netherlands B.V.
Groningen, Netherlands, 9713 GZ