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CompletedNCT04608513Updated Oct 15, 2021

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

A Phase 1 interventional study of ACT-1014-6470 and Placebo in Healthy, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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).
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    ACT-1014-6470 single dose (dose level 1)

    Soft capsule for oral administration

    Drug: ACT-1014-6470

  • Placebo comparator
    Placebo single dose (dose level 1)

    Soft capsule for oral administration

    Drug: Placebo

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

    Soft capsule for oral administration

    Drug: ACT-1014-6470

  • Placebo comparator
    Placebo single dose (dose level 2)

    Soft capsule for oral administration

    Drug: Placebo

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

    Soft capsule for oral administration

    Drug: ACT-1014-6470

  • Placebo comparator
    Placebo multiple dose (dose level 1)

    Soft capsule for oral administration

    Drug: Placebo

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

    Soft capsule for oral administration

    Drug: ACT-1014-6470

  • Placebo comparator
    Placebo multiple dose (dose level 2)

    Soft capsule for oral administration

    Drug: Placebo

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

    Soft capsule for oral administration

    Drug: ACT-1014-6470

  • Placebo comparator
    Placebo multiple dose (dose level 3)

    Soft capsule for oral administration

    Drug: Placebo

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

    Soft capsule for oral administration

    Drug: ACT-1014-6470

  • Placebo comparator
    Placebo multiple dose (dose level 4)

    Soft capsule for oral administration

    Drug: Placebo

Interventions

  • DrugACT-1014-6470

    Soft capsules for oral administration

  • DrugPlacebo

    Soft capsules for oral administration

06

What researchers measure

Primary outcomes

  1. Safety profile including incidence of treatment-emergent adverse events.

    Time frame: 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 outcomes

  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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

07

Study locations

1 site
  • Parexel International GmbH Klinikum Westend
    Berlin, 14050, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04608513
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Responsible party
Sponsor
First posted
Oct 29, 2020
Start date
Nov 16, 2020
Primary completion
Sep 20, 2021
Completion
Sep 20, 2021
Last update
Oct 15, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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