HealthyPhase 1NCT04608513
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 study testing ACT-1014-6470 in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACT-1014-6470
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 16 Nov 2020to 20 Sep 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
A safety and tolerability study in healthy subjects including examination of how the body takes up, distributes, and gets rid of ACT-1014-6470
- Conditions
- Healthy
- Being tested
- ACT-1014-6470, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-1014-6470Drug
Soft capsules for oral administration
PlaceboDrug
Soft capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| ACT-1014-6470 single dose (dose level 1) | Experimental | Soft capsule for oral administration Receives: Drug: ACT-1014-6470 |
| Placebo single dose (dose level 1) | Placebo comparator | Soft capsule for oral administration Receives: Drug: Placebo |
| ACT-1014-6470 single dose (dose level 2) | Experimental | Soft capsule for oral administration Receives: Drug: ACT-1014-6470 |
| Placebo single dose (dose level 2) | Placebo comparator | Soft capsule for oral administration Receives: Drug: Placebo |
| ACT-1014-6470 multiple dose (dose level 1) | Experimental | Soft capsule for oral administration Receives: Drug: ACT-1014-6470 |
| Placebo multiple dose (dose level 1) | Placebo comparator | Soft capsule for oral administration Receives: Drug: Placebo |
| ACT-1014-6470 multiple dose (dose level 2) | Experimental | Soft capsule for oral administration Receives: Drug: ACT-1014-6470 |
| Placebo multiple dose (dose level 2) | Placebo comparator | Soft capsule for oral administration Receives: Drug: Placebo |
| ACT-1014-6470 multiple dose (dose level 3) | Experimental | Soft capsule for oral administration Receives: Drug: ACT-1014-6470 |
| Placebo multiple dose (dose level 3) | Placebo comparator | Soft capsule for oral administration Receives: Drug: Placebo |
| ACT-1014-6470 multiple dose (dose level 4) | Experimental | Soft capsule for oral administration Receives: Drug: ACT-1014-6470 |
| Placebo multiple dose (dose level 4) | Placebo comparator | Soft capsule for oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile including incidence of treatment-emergent adverse events.
Measured: 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 (9)
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).
Measured: 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).
Part A - Single ascending dose (SAD): Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf).
Measured: 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).
Part A - Single ascending dose (SAD): Maximum plasma concentration (Cmax).
Measured: 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).
Part A - Single ascending dose (SAD): Time to reach Cmax (tmax).
Measured: 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).
Part A - Single ascending dose (SAD): Terminal half-life (t½).
Measured: 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).
Part B - Multiple ascending dose (MAD): AUC during a dosing interval (AUCτ) following the first and the last dose.
Measured: 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).
Part B - Multiple ascending dose (MAD): Cmax of the first and the last dosing interval.
Measured: 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).
Part B - Multiple ascending dose (MAD): tmax of the first and the last dosing interval.
Measured: 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).
Part B - Multiple ascending dose (MAD): t½ after last dose administration.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start16 Nov 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- Single-center, double-blind, randomized, placebo-controlled, single- and multiple-ascending dose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 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
- NCT04608513
- Sponsor's protocol ID
- ID-087-102
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2020
- Last updated
- 15 Oct 2021
- 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 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04608513
- Acronym / sponsor ID
- ID-087-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 29 Oct 2020 (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.
A safety and tolerability study in healthy subjects including examination of how the body takes up, distributes, and gets rid of ACT-1014-6470
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
- Model description
- Single-center, double-blind, randomized, placebo-controlled, single- and multiple-ascending dose
| Arm | Type | Receives |
|---|---|---|
| ACT-1014-6470 single dose (dose level 1) | Experimental | Drug: ACT-1014-6470Soft capsule for oral administration |
| Placebo single dose (dose level 1) | Placebo comparator | Drug: PlaceboSoft capsule for oral administration |
| ACT-1014-6470 single dose (dose level 2) | Experimental | Drug: ACT-1014-6470Soft capsule for oral administration |
| Placebo single dose (dose level 2) | Placebo comparator | Drug: PlaceboSoft capsule for oral administration |
| ACT-1014-6470 multiple dose (dose level 1) | Experimental | Drug: ACT-1014-6470Soft capsule for oral administration |
| Placebo multiple dose (dose level 1) | Placebo comparator | Drug: PlaceboSoft capsule for oral administration |
| ACT-1014-6470 multiple dose (dose level 2) | Experimental | Drug: ACT-1014-6470Soft capsule for oral administration |
| Placebo multiple dose (dose level 2) | Placebo comparator | Drug: PlaceboSoft capsule for oral administration |
| ACT-1014-6470 multiple dose (dose level 3) | Experimental | Drug: ACT-1014-6470Soft capsule for oral administration |
| Placebo multiple dose (dose level 3) | Placebo comparator | Drug: PlaceboSoft capsule for oral administration |
| ACT-1014-6470 multiple dose (dose level 4) | Experimental | Drug: ACT-1014-6470Soft capsule for oral administration |
| Placebo multiple dose (dose level 4) | Placebo comparator | Drug: PlaceboSoft capsule for oral administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
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-1014-6470Soft capsules for oral administration | Drug | ACT-1014-6470 multiple dose (dose level 1), ACT-1014-6470 multiple dose (dose level 2), ACT-1014-6470 multiple dose (dose level 3), ACT-1014-6470 multiple dose (dose level 4), ACT-1014-6470 single dose (dose level 1), ACT-1014-6470 single dose (dose level 2) |
| PlaceboSoft capsules for oral administration | Drug | Placebo multiple dose (dose level 1), Placebo multiple dose (dose level 2), Placebo multiple dose (dose level 3), Placebo multiple dose (dose level 4), Placebo single dose (dose level 1), Placebo single dose (dose level 2) |
Primary outcome
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).
9 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
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).
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).
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 15 Oct 2021.
- 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-1014-6470 in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
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 7 inclusion and 5 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 15 Oct 2021. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
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).). 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 15 Oct 2021.