HealthyPhase 1NCT04798209
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects
A Phase 1 study testing ACT-777991 (SAD), ACT-777991 (MAD) and 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability) in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects. 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-777991 (SAD), ACT-777991 (MAD) and 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Jan 2021to 21 May 2022
- 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
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a highly effective method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- General Exclusion Criteria:
- 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.
- Exclusion Criteria for the absorption,distribution, metabolism and excretion (ADME) evaluation:
- Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 milli sievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed workers, as defined in the relevant Ionising Radiation Regulations, must not participate in the study.
- Participation in any study involving administration of any Carbon-14 (14C) radiolabeled compound within the 12 months prior to Screening.
Who cannot join
- Pregnant or lactating women.
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-777991 in Healthy Subjects
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects.
- Conditions
- Healthy
- Being tested
- ACT-777991 (SAD), ACT-777991 (MAD), Placebo (SAD), Placebo (MAD), 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-777991 (SAD)Drug
ACT-777991 administered as hard capsules for oral use.
ACT-777991 (MAD)Drug
ACT-777991 administered as hard capsules for oral use, once daily.
Placebo (SAD)Drug
ACT-777991 matching placebo administered as hard capsules for oral use.
Placebo (MAD)Drug
Matching placebo administered as hard capsules for oral use, once daily.
14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)Drug
Single dose of 14C-ACT-777991 microtracer, administered intravenously.
Microtracer matching placebo (SAD - Absolute Bioavailability)Drug
Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously.
14C-ACT-777991 microtracer (MAD - ADME)Drug
Single dose of 14C-ACT-777991 microtracer, oral solution..
Microtracer matching placebo (MAD - ADME)Drug
Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution.
| Study group | Role | What they receive |
|---|---|---|
| Part A (single ascending dose) Dose A1 | Experimental | Single dose A1 of ACT-777991. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part A (single ascending dose arm) Dose A2 | Experimental | Single dose A2 of ACT-777991. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part A (single ascending dose arm) Dose A3 | Experimental | Single dose A3 of ACT-777991. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part A (single ascending dose arm) Dose A4 | Experimental | Single dose A4 of ACT-777991 under fasted and fed conditions, separated by at least 14 days. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part A (single ascending dose arm) Dose A5 | Experimental | Single dose A5 of ACT-777991. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part A (single ascending dose arm) Dose A6 | Experimental | Single dose A6 of ACT-777991. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part A (single ascending dose arm) Dose A7 | Experimental | Single dose A7 of ACT-777991. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part A (single ascending dose arm) Dose A8 | Experimental | Single dose A8 of ACT-777991. Receives: Drug: ACT-777991 (SAD); Drug: Placebo (SAD) |
| Part B (multiple ascending dose) Dose B1 | Experimental | Multiple doses B1 of ACT-777991. Receives: Drug: ACT-777991 (MAD); Drug: Placebo (MAD) |
| Part B (multiple ascending dose) Dose B2 | Experimental | Multiple doses B2 of ACT-777991. Receives: Drug: ACT-777991 (MAD); Drug: Placebo (MAD) |
| Part B (multiple ascending dose) Dose B3 | Experimental | Multiple doses B3 of ACT-777991. Receives: Drug: ACT-777991 (MAD); Drug: Placebo (MAD) |
| Part B (multiple ascending dose) Dose B4 | Experimental | Multiple doses B4 of ACT-777991. Receives: Drug: ACT-777991 (MAD); Drug: Placebo (MAD) |
| Part B (multiple ascending dose) Dose B5 | Experimental | Multiple doses B5 of ACT-777991. Receives: Drug: ACT-777991 (MAD); Drug: Placebo (MAD) |
| Part A (single ascending dose) Absolute Bioavailability | Experimental | Single dose of ACT-777991 plus a single dose of 14C-ACT-777991. At one of the dose levels from A4 to A8. Receives: Drug: 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability); Drug: Microtracer matching placebo (SAD - Absolute Bioavailability) |
| Part B (multiple ascending dose) ADME | Experimental | Multiple doses of ACT-777991 plus a single dose of 14C-ACT-777991. At one of the dose levels from B1 to B5. Receives: Drug: 14C-ACT-777991 microtracer (MAD - ADME); Drug: Microtracer matching placebo (MAD - ADME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events.
Measured: From first dose on Day 1 to Day 4 after the last dose was administered
Secondary outcomes (12)
All cohorts: 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) of ACT-777991
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf) of ACT-777991
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Maximum plasma concentration (Cmax) of ACT-777991
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Time to reach Cmax (tmax) of ACT-777991
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Terminal half-life (t1/2) of ACT-777991
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
Part A (SAD): Absolute bioavailability of ACT-777991
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
Part B (MAD): Excretion of radioactivity in urine and feces
Measured: Samples will be collected at predefined time points from Day 1 to Day X+3 (where Day X = day of last study treatment administration)
Part B (MAD): AUC during a dosing interval (AUCτ) following the first and the last dose of ACT-777991.
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
Part A (SAD): Food effect evaluation only: AUC0-inf of ACT-777991 under fed conditions
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4.
Part A (SAD): Food effect evaluation only: Cmax of ACT-777991 under fed conditions
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4.
Part A (SAD): Food effect evaluation only: tmax of ACT-777991 under fed conditions
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4.
Part A (SAD): Food effect evaluation only: t1/2 of ACT 777991 under fed conditions
Measured: Blood samples will be collected at predefined time points from Day 1 to Day 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start29 Jan 2021
- Primary completion26 Jan 2022
- Study completion21 May 2022
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
- Sequential
- Model description
- Single-center, double-blind, randomized, placebo-controlled Phase 1 study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798209
- Sponsor's protocol ID
- ID-089-101
- Other IDs
- 2020-004464-26
- Status last verified
- Jun 2022
- First submitted
- 3 Mar 2021
- Last updated
- 21 Jun 2022
- 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 21 Jun 2022. 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-777991 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04798209
- Acronym / sponsor ID
- ID-089-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 15 Mar 2021 (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 study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 15
- Model description
- Single-center, double-blind, randomized, placebo-controlled Phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Part A (single ascending dose) Dose A1 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A1 of ACT-777991. |
| Part A (single ascending dose arm) Dose A2 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A2 of ACT-777991. |
| Part A (single ascending dose arm) Dose A3 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A3 of ACT-777991. |
| Part A (single ascending dose arm) Dose A4 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A4 of ACT-777991 under fasted and fed conditions, separated by at least 14 days. |
| Part A (single ascending dose arm) Dose A5 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A5 of ACT-777991. |
| Part A (single ascending dose arm) Dose A6 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A6 of ACT-777991. |
| Part A (single ascending dose arm) Dose A7 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A7 of ACT-777991. |
| Part A (single ascending dose arm) Dose A8 | Experimental | Drug: ACT-777991 (SAD), Drug: Placebo (SAD)Single dose A8 of ACT-777991. |
| Part B (multiple ascending dose) Dose B1 | Experimental | Drug: ACT-777991 (MAD), Drug: Placebo (MAD)Multiple doses B1 of ACT-777991. |
| Part B (multiple ascending dose) Dose B2 | Experimental | Drug: ACT-777991 (MAD), Drug: Placebo (MAD)Multiple doses B2 of ACT-777991. |
| Part B (multiple ascending dose) Dose B3 | Experimental | Drug: ACT-777991 (MAD), Drug: Placebo (MAD)Multiple doses B3 of ACT-777991. |
| Part B (multiple ascending dose) Dose B4 | Experimental | Drug: ACT-777991 (MAD), Drug: Placebo (MAD)Multiple doses B4 of ACT-777991. |
| Part B (multiple ascending dose) Dose B5 | Experimental | Drug: ACT-777991 (MAD), Drug: Placebo (MAD)Multiple doses B5 of ACT-777991. |
| Part A (single ascending dose) Absolute Bioavailability | Experimental | Drug: 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability), Drug: Microtracer matching placebo (SAD - Absolute Bioavailability)Single dose of ACT-777991 plus a single dose of 14C-ACT-777991. At one of the dose levels from A4 to A8. |
| Part B (multiple ascending dose) ADME | Experimental | Drug: 14C-ACT-777991 microtracer (MAD - ADME), Drug: Microtracer matching placebo (MAD - ADME)Multiple doses of ACT-777991 plus a single dose of 14C-ACT-777991. At one of the dose levels from B1 to B5. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a highly effective method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- 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.
- Exclusion Criteria for the absorption,distribution, metabolism and excretion (ADME) evaluation:
Key exclusion criteria (1 listed)
- Pregnant or lactating women.
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-777991 (SAD)ACT-777991 administered as hard capsules for oral use. | Drug | Part A (single ascending dose arm) Dose A2, Part A (single ascending dose arm) Dose A3, Part A (single ascending dose arm) Dose A4, Part A (single ascending dose arm) Dose A5, Part A (single ascending dose arm) Dose A6, Part A (single ascending dose arm) Dose A7, Part A (single ascending dose arm) Dose A8, Part A (single ascending dose) Dose A1 |
| ACT-777991 (MAD)ACT-777991 administered as hard capsules for oral use, once daily. | Drug | Part B (multiple ascending dose) Dose B1, Part B (multiple ascending dose) Dose B2, Part B (multiple ascending dose) Dose B3, Part B (multiple ascending dose) Dose B4, Part B (multiple ascending dose) Dose B5 |
| Placebo (SAD)ACT-777991 matching placebo administered as hard capsules for oral use. | Drug | Part A (single ascending dose arm) Dose A2, Part A (single ascending dose arm) Dose A3, Part A (single ascending dose arm) Dose A4, Part A (single ascending dose arm) Dose A5, Part A (single ascending dose arm) Dose A6, Part A (single ascending dose arm) Dose A7, Part A (single ascending dose arm) Dose A8, Part A (single ascending dose) Dose A1 |
| Placebo (MAD)Matching placebo administered as hard capsules for oral use, once daily. | Drug | Part B (multiple ascending dose) Dose B1, Part B (multiple ascending dose) Dose B2, Part B (multiple ascending dose) Dose B3, Part B (multiple ascending dose) Dose B4, Part B (multiple ascending dose) Dose B5 |
| 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)Single dose of 14C-ACT-777991 microtracer, administered intravenously. | Drug | Part A (single ascending dose) Absolute Bioavailability |
| Microtracer matching placebo (SAD - Absolute Bioavailability)Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously. | Drug | Part A (single ascending dose) Absolute Bioavailability |
| 14C-ACT-777991 microtracer (MAD - ADME)Single dose of 14C-ACT-777991 microtracer, oral solution.. | Drug | Part B (multiple ascending dose) ADME |
| Microtracer matching placebo (MAD - ADME)Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution. | Drug | Part B (multiple ascending dose) ADME |
Primary outcome
Incidence of treatment-emergent adverse events.
Time frame: From first dose on Day 1 to Day 4 after the last dose was administered
12 secondary outcomes
All cohorts: 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) of ACT-777991
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf) of ACT-777991
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Maximum plasma concentration (Cmax) of ACT-777991
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Time to reach Cmax (tmax) of ACT-777991
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
All cohorts: Terminal half-life (t1/2) of ACT-777991
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
Part A (SAD): Absolute bioavailability of ACT-777991
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
Part B (MAD): Excretion of radioactivity in urine and feces
Time frame: Samples will be collected at predefined time points from Day 1 to Day X+3 (where Day X = day of last study treatment administration)
Part B (MAD): AUC during a dosing interval (AUCτ) following the first and the last dose of ACT-777991.
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4 after the last dose was administered
Part A (SAD): Food effect evaluation only: AUC0-inf of ACT-777991 under fed conditions
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4.
Part A (SAD): Food effect evaluation only: Cmax of ACT-777991 under fed conditions
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4.
Part A (SAD): Food effect evaluation only: tmax of ACT-777991 under fed conditions
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4.
Part A (SAD): Food effect evaluation only: t1/2 of ACT 777991 under fed conditions
Time frame: Blood samples will be collected at predefined time points from Day 1 to Day 4.
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 21 Jun 2022.
- 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.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
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-777991 (SAD), ACT-777991 (MAD) and 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability) in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
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 8 inclusion and 1 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 21 Jun 2022. 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 Netherlands. 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?
Incidence of treatment-emergent adverse events. (time frame: From first dose on Day 1 to Day 4 after the last dose was administered). 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 21 Jun 2022.