Status:
COMPLETED
Study in Healthy Subjects to Examine the Safety and Tolerability of ACT-1004-1239 Given as Multiple, Gradually Increasing Doses and to Examine the Effects of ACT-1004-1239 on the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-1004-1239
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Study in healthy subjects to examine the safety and tolerability of ACT-1004-1239 given as multiple, gradually increasing doses and to examine the effects of ACT-1004-1239 on the body and the way the ...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure.
- Healthy male or female subject aged between 18 and 55 years (inclusive) at Screening.
- A female subject of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day - 1 and must agree to 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.
- A female subject of non-childbearing potential must be postmenopausal, or must have a medical history of previous bilateral salpingectomy, bilateral salpingo-oophorectomy, hysterectomy, premature ovarian failure, XY genotype, Turner syndrome, or uterine agenesis.
- A male subject must use adequate contraception from first study treatment administration up to at least 90 days after last administration unless he is vasectomized.
- A male subject must agree to refrain from donation of semen from first study treatment administration up to at least 90 days after last administration.
Exclusion
- Previous exposure to ACT-1004-1239.
- Known hypersensitivity to ACT-1004-1239, or any of its excipients.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
- Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study.
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Pregnant or lactating woman.
- Any cardiac condition or illness that may jeopardize the safety of the study subject per investigator judgment based on medical history or 12-lead ECG measured at Screening.
- Any immunosuppressive treatment within 6 weeks or 5x terminal half-life (t½), whichever is longer, before study treatment administration.
Key Trial Info
Start Date :
July 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04286750
Start Date
July 11 2020
End Date
September 25 2020
Last Update
January 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
BlueClinical Phase 1 Hospital de Prelado
Porto, Portugal, 4250-449