A Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects

Sponsor
Idorsia Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04608513
Collaborator
(none)
46
1
12
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Study Details

Study Description

Brief Summary

A safety and tolerability study in healthy subjects including examination of how the body takes up, distributes, and gets rid of ACT-1014-6470

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-center, double-blind, randomized, placebo-controlled, single- and multiple-ascending doseSingle-center, double-blind, randomized, placebo-controlled, single- and multiple-ascending dose
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Single-center, Double-blind, Randomized, Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
Actual Study Start Date :
Nov 16, 2020
Actual Primary Completion Date :
Sep 20, 2021
Actual Study Completion Date :
Sep 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACT-1014-6470 single dose (dose level 1)

Soft capsule for oral administration

Drug: ACT-1014-6470
Soft capsules for oral administration

Placebo Comparator: Placebo single dose (dose level 1)

Soft capsule for oral administration

Drug: Placebo
Soft capsules for oral administration

Experimental: ACT-1014-6470 single dose (dose level 2)

Soft capsule for oral administration

Drug: ACT-1014-6470
Soft capsules for oral administration

Placebo Comparator: Placebo single dose (dose level 2)

Soft capsule for oral administration

Drug: Placebo
Soft capsules for oral administration

Experimental: ACT-1014-6470 multiple dose (dose level 1)

Soft capsule for oral administration

Drug: ACT-1014-6470
Soft capsules for oral administration

Placebo Comparator: Placebo multiple dose (dose level 1)

Soft capsule for oral administration

Drug: Placebo
Soft capsules for oral administration

Experimental: ACT-1014-6470 multiple dose (dose level 2)

Soft capsule for oral administration

Drug: ACT-1014-6470
Soft capsules for oral administration

Placebo Comparator: Placebo multiple dose (dose level 2)

Soft capsule for oral administration

Drug: Placebo
Soft capsules for oral administration

Experimental: ACT-1014-6470 multiple dose (dose level 3)

Soft capsule for oral administration

Drug: ACT-1014-6470
Soft capsules for oral administration

Placebo Comparator: Placebo multiple dose (dose level 3)

Soft capsule for oral administration

Drug: Placebo
Soft capsules for oral administration

Experimental: ACT-1014-6470 multiple dose (dose level 4)

Soft capsule for oral administration

Drug: ACT-1014-6470
Soft capsules for oral administration

Placebo Comparator: Placebo multiple dose (dose level 4)

Soft capsule for oral administration

Drug: Placebo
Soft capsules for oral administration

Outcome Measures

Primary Outcome Measures

  1. Safety profile including incidence of treatment-emergent adverse events. [Safety and tolerability assessments will be performed at predefined time points from Day 1 to Day 4 in Part A and Day 1 to Day 10 in Part B (total duration: max. 50 days).]

Secondary Outcome Measures

  1. Part A - Single ascending dose (SAD): Area under the plasma concentration-time curve (AUC) from zero to time t of the last measured concentration above the limit of quantification (AUC0-t). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]

  2. Part A - Single ascending dose (SAD): Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]

  3. Part A - Single ascending dose (SAD): Maximum plasma concentration (Cmax). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]

  4. Part A - Single ascending dose (SAD): Time to reach Cmax (tmax). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]

  5. Part A - Single ascending dose (SAD): Terminal half-life (t½). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]

  6. Part B - Multiple ascending dose (MAD): AUC during a dosing interval (AUCτ) following the first and the last dose. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]

  7. Part B - Multiple ascending dose (MAD): Cmax of the first and the last dosing interval. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]

  8. Part B - Multiple ascending dose (MAD): tmax of the first and the last dosing interval. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]

  9. Part B - Multiple ascending dose (MAD): t½ after last dose administration. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

General criteria

  • Signed informed consent prior to any study-mandated procedure.

  • Healthy male subjects (both study parts) and female subjects of nonchildbearing potential (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 that 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 (from Screening, during the entire study, and for at least 3 months after last study treatment intake) a highly effective method of contraception.

Criteria for Part B only:

• 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:
  • Previous exposure to the study medication.

  • 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.

  • Relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to Screening and/or ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and/or evidence of immune dysfunction based on laboratory tests at Screening.

  • Any signs or symptoms of active, ongoing infection judged to be clinically relevant by the investigator (special attention should be given to clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, or fatigue).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parexel International GmbH Klinikum Westend Berlin Germany 14050

Sponsors and Collaborators

  • Idorsia Pharmaceuticals Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT04608513
Other Study ID Numbers:
  • ID-087-102
First Posted:
Oct 29, 2020
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 15, 2021