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CompletedNCT04123288Updated Feb 25, 2020

A Study to Compare a Single-dose of Two Different Formulations of ACT-709478 in Healthy Men

A Phase 1 interventional study of ACT-709478 and ACT-709478 in Healthy Subjects, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Czechia. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

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

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the pharmacokinetics of 2 different formulations of ACT-709478 in healthy male participants. The participants will be treated in a crossover design with 2 different treatment periods. Pharmacokinetics (PK) is the study of the absorption and breakdown of the study drug in the body.

The duration of participation in this study is approximately 8 weeks from screening to the end of study visit. A screening visit is required within 21 to 3 days prior to the start of the study to determine whether the participant qualifies and is willing to enter in this research study. This study requires the participant to have two in-patient stays in the research clinic. Each in-patient stay is planned for 5 days (4 nights). Eleven days after each dose the participant will have an examination. There will be an in-between period (i.e., time between the end of period 1 and study treatment administration in Period 2) of 7 to 14 days. A safety follow-up telephone call for all participants who have received at least one study treatment will take place 30 to 40 days after the end of study examination or study discontinuation.

02

Conditions studied

  • Healthy Subjects
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 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
  • Body mass index of 18.5-28.0 kg/m2 (inclusive) at Screening.
  • Czech citizen with the ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the requirements of the study.
  • Systolic blood pressure 100 to 145 mmHg, diastolic blood pressure 60 to 90 mmHg, and pulse rate 50 to 90 bpm (inclusive) after 5 min in the supine position at Screening.
  • Healthy on the basis of physical examination, cardiovascular assessments, and laboratory tests.

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to any of the excipients of the study treatment formulations.
  • Participation in a clinical study involving study treatment administration within 3 months or 5 half-lives (whichever is longer) prior to Screening, or in more than 4 clinical studies within 1 year prior to Screening.
  • 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 treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed).
  • Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study.
  • Any cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or ECG evaluations.
  • History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation).
  • PR Interval on 12-lead ECG greater than 200 ms at Screening.
  • Previous treatment with any prescribed medications (including vaccines) or over-the-counter medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks or 5 t½ (whichever is longer) prior to first study treatment administration.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Test drug formulation

    Test drug 60 mg single dose

    Drug: ACT-709478

  • Active comparator
    Reference drug formulation

    60 mg single dose

    Drug: ACT-709478

Interventions

  • DrugACT-709478

    1 film-coated minitablet contains 2 mg of ACT-709478

  • DrugACT-709478

    1 hard capsule contains 10 mg of ACT-709478.

06

What researchers measure

Primary outcomes

  1. The area under the plasma concentration-time curve (AUC 0-t).

    Time frame: Multiple time points; duration for up to 264 hours in each treatment period.

  2. The area under the plasma concentration-time curve (AUC 0-inf)

    Time frame: Multiple time points; duration for up to 264 hours in each treatment period.

  3. The maximum plasma concentration (Cmax)

    Time frame: Multiple time points; duration for up to 264 hours in each treatment period.

  4. The time to reach Cmax (tmax)

    Time frame: Multiple time points; duration for up to 264 hours in each treatment period.

  5. The terminal elimination half-life (t1/2)

    Time frame: Multiple time points; duration for up to 264 hours in each treatment period.

07

Study locations

1 site
  • CEPHA s.r.o.
    Pilsen, 323 00, Czechia
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 Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04123288
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Responsible party
Sponsor
First posted
Oct 10, 2019
Start date
Dec 16, 2019
Primary completion
Feb 5, 2020
Completion
Feb 5, 2020
Last update
Feb 25, 2020

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 Feb 2020. You cannot join it, but the record below documents what was studied.

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