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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: ACT-1004-1239

• Registration Number: NCT04286750
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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 body takes up, distributes, and gets rid of ACT-1004-1239

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Study Start: 2020-07-11
• Primary Completion: 2020-09-25
• Study Completion: 2020-09-25
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Each dose level will be investigated in a group of 10 male and female subjects (ratio 1:1, male:female), with 8 subjects being administered ACT-1004-239 and 2 subjects matching placebo (ratio 1:1, male:female). Sentinel dosing will be applied at each dose level, i.e., in each group two subjects (ratio 1:1, male:female) will initially receive study treatment (1 on active treatment and 1 on placebo).
ACT-1004-1239 Dose level 1 (30 mg) to 5	ACT-1004-1239	Each dose level will be investigated in a group of 10 male and female subjects (ratio 1:1, male:female), with 8 subjects being administered ACT-1004-239 and 2 subjects matching placebo (ratio 1:1, male:female). Sentinel dosing will be applied at each dose level, i.e., in each group two subjects (ratio 1:1, male:female) will initially receive study treatment (1 on active treatment and 1 on placebo).

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent (serious) adverse events	From first study treatment administration up to End of Study (EOS). Duration: up to 6 weeks

Trial Locations

Locations (1)

BlueClinical Phase 1 Hospital de Prelado; 🇵🇹 Porto, Portugal