Healthy SubjectsPhase 1NCT04123288
A Study to Compare a Single-dose of Two Different Formulations of ACT-709478 in Healthy Men
A Phase 1 study testing ACT-709478 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ACT-709478
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Dec 2019to 5 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open-label, Randomized, Two-way Crossover Study to Compare the Single-dose Pharmacokinetics of Pediatric Minitablet and Adult Capsule Formulations of ACT-709478 in Healthy Male Subjects
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.
- Conditions
- Healthy Subjects
- Being tested
- ACT-709478
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-709478Drug
1 film-coated minitablet contains 2 mg of ACT-709478
ACT-709478Drug
1 hard capsule contains 10 mg of ACT-709478.
| Study group | Role | What they receive |
|---|---|---|
| Test drug formulation | Experimental | Test drug 60 mg single dose Receives: Drug: ACT-709478 |
| Reference drug formulation | Active comparator | 60 mg single dose Receives: Drug: ACT-709478 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve (AUC 0-t).
Measured: Multiple time points; duration for up to 264 hours in each treatment period.
The area under the plasma concentration-time curve (AUC 0-inf)
Measured: Multiple time points; duration for up to 264 hours in each treatment period.
The maximum plasma concentration (Cmax)
Measured: Multiple time points; duration for up to 264 hours in each treatment period.
The time to reach Cmax (tmax)
Measured: Multiple time points; duration for up to 264 hours in each treatment period.
The terminal elimination half-life (t1/2)
Measured: Multiple time points; duration for up to 264 hours in each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start16 Dec 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123288
- Sponsor's protocol ID
- ID-083-104
- Other IDs
- 2019-002005-22, 2019
- Status last verified
- Feb 2020
- First submitted
- 9 Oct 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-label, Randomized, Two-way Crossover Study to Compare the Single-dose Pharmacokinetics of Pediatric Minitablet and Adult Capsule Formulations of ACT-709478 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04123288
- Acronym / sponsor ID
- ID-083-104
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test drug formulation | Experimental | Drug: ACT-709478Test drug 60 mg single dose |
| Reference drug formulation | Active comparator | Drug: ACT-70947860 mg single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-7094781 film-coated minitablet contains 2 mg of ACT-709478 | Drug | Test drug formulation |
| ACT-7094781 hard capsule contains 10 mg of ACT-709478. | Drug | Reference drug formulation |
Primary outcome
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.
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.
The maximum plasma concentration (Cmax)
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
The time to reach Cmax (tmax)
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
The terminal elimination half-life (t1/2)
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-709478 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.