HealthyPhase 1NCT04183686
A Study to Examine 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 (SAD), ACT-1014-6470 (MAD) and 14C-ACT-1014-6470 microtracer 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-1014-6470 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-1014-6470 (SAD), ACT-1014-6470 (MAD) and 14C-ACT-1014-6470 microtracer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Nov 2019to 15 Mar 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 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 < 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.
Who cannot join
- Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 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 14C radiolabeled compound within the 12 months prior to Screening.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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, Including Food Effect, Mass Balance, and Metabolite Profiling
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects
- Conditions
- Healthy
- Being tested
- ACT-1014-6470 (SAD), ACT-1014-6470 (MAD), Placebo (SAD), Placebo (MAD), 14C-ACT-1014-6470 microtracer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-1014-6470 (SAD)Drug
Single dose of ACT-1014-6470; soft capsules for oral use.
ACT-1014-6470 (MAD)Drug
Multiple doses of ACT-1014-6470; soft capsules for oral use.
Placebo (SAD)Drug
Single dose of matching placebo; soft capsules for oral use.
Placebo (MAD)Drug
Multiple doses of matching placebo; soft capsules for oral use.
14C-ACT-1014-6470 microtracerDrug
Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.
14C-ACT-1014-6470 microtracer placeboDrug
Single dose of matching placebo; soft capsules for oral use.
| Study group | Role | What they receive |
|---|---|---|
| Part A (SAD): Dose A1 | Experimental | Single dose A1 of ACT-1014-6470; soft capsule for oral use. Receives: Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD) |
| Part A (SAD): Dose A2 | Experimental | Single dose A2 of ACT-1014-6470; soft capsule for oral use. Receives: Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD) |
| Part A (SAD): Dose A3 | Experimental | Single dose A3 of ACT-1014-6470 under fasted and fed conditions, separated by at least 18 days; soft capsule for oral use. Receives: Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD) |
| Part A (SAD): Dose A4 | Experimental | Single dose A4 of ACT-1014-6470; soft capsule for oral use. Receives: Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD); Drug: 14C-ACT-1014-6470 microtracer; Drug: 14C-ACT-1014-6470 microtracer placebo |
| Part A (SAD): Dose A5 | Experimental | Single dose A5 of ACT-1014-6470; soft capsule for oral use. Receives: Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD) |
| Part A (SAD): Dose A6 | Experimental | Single dose A6 of ACT-1014-6470; soft capsule for oral use. Receives: Drug: ACT-1014-6470 (SAD); Drug: Placebo (SAD) |
| Part B (MAD): Dose B1 | Experimental | Multiple doses B1 of ACT-1014-6470; soft capsules for oral use. Receives: Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD) |
| Part B (MAD): Dose B2 | Experimental | Multiple doses B2 of ACT-1014-6470; soft capsules for oral use. Receives: Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD) |
| Part B (MAD): Dose B3 | Experimental | Multiple doses B3 of ACT-1014-6470; soft capsules for oral use. Receives: Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD) |
| Part B (MAD): Dose B4 | Experimental | Multiple doses B4 of ACT-1014-6470; soft capsules for oral use. Receives: Drug: ACT-1014-6470 (MAD); Drug: Placebo (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf)
Blood samples for determination of PK parameters will be collected at predefined time points from Day 1 to Day 4 of Part A (SAD, Day 1 to Day 8 for ADME cohort A4) and from Day 1 to Day X+3 of Part B (MAD, with Day X = day of last study treatment administration).
Measured: Total duration of assessments: up to 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start25 Nov 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
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
- 88 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
- NCT04183686
- Sponsor's protocol ID
- ID-087-101
- Status last verified
- Aug 2020
- First submitted
- 26 Nov 2019
- Last updated
- 12 Aug 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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, Including Food Effect, Mass Balance, and Metabolite Profiling
- ClinicalTrials.gov ID
- NCT04183686
- Acronym / sponsor ID
- ID-087-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 3 Dec 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.
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 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
- 10
- Model description
- Single-center, double-blind, randomized, placebo-controlled Phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Part A (SAD): Dose A1 | Experimental | Drug: ACT-1014-6470 (SAD), Drug: Placebo (SAD)Single dose A1 of ACT-1014-6470; soft capsule for oral use. |
| Part A (SAD): Dose A2 | Experimental | Drug: ACT-1014-6470 (SAD), Drug: Placebo (SAD)Single dose A2 of ACT-1014-6470; soft capsule for oral use. |
| Part A (SAD): Dose A3 | Experimental | Drug: ACT-1014-6470 (SAD), Drug: Placebo (SAD)Single dose A3 of ACT-1014-6470 under fasted and fed conditions, separated by at least 18 days; soft capsule for oral use. |
| Part A (SAD): Dose A4 | Experimental | Drug: ACT-1014-6470 (SAD), Drug: Placebo (SAD), Drug: 14C-ACT-1014-6470 microtracer, Drug: 14C-ACT-1014-6470 microtracer placeboSingle dose A4 of ACT-1014-6470; soft capsule for oral use. |
| Part A (SAD): Dose A5 | Experimental | Drug: ACT-1014-6470 (SAD), Drug: Placebo (SAD)Single dose A5 of ACT-1014-6470; soft capsule for oral use. |
| Part A (SAD): Dose A6 | Experimental | Drug: ACT-1014-6470 (SAD), Drug: Placebo (SAD)Single dose A6 of ACT-1014-6470; soft capsule for oral use. |
| Part B (MAD): Dose B1 | Experimental | Drug: ACT-1014-6470 (MAD), Drug: Placebo (MAD)Multiple doses B1 of ACT-1014-6470; soft capsules for oral use. |
| Part B (MAD): Dose B2 | Experimental | Drug: ACT-1014-6470 (MAD), Drug: Placebo (MAD)Multiple doses B2 of ACT-1014-6470; soft capsules for oral use. |
| Part B (MAD): Dose B3 | Experimental | Drug: ACT-1014-6470 (MAD), Drug: Placebo (MAD)Multiple doses B3 of ACT-1014-6470; soft capsules for oral use. |
| Part B (MAD): Dose B4 | Experimental | Drug: ACT-1014-6470 (MAD), Drug: Placebo (MAD)Multiple doses B4 of ACT-1014-6470; soft capsules for oral use. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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 < 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.
Key exclusion criteria (3 listed)
- Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 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 14C radiolabeled compound within the 12 months prior to Screening.
- 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-1014-6470 (SAD)Single dose of ACT-1014-6470; soft capsules for oral use. | Drug | Part A (SAD): Dose A1, Part A (SAD): Dose A2, Part A (SAD): Dose A3, Part A (SAD): Dose A4, Part A (SAD): Dose A5, Part A (SAD): Dose A6 |
| ACT-1014-6470 (MAD)Multiple doses of ACT-1014-6470; soft capsules for oral use. | Drug | Part B (MAD): Dose B1, Part B (MAD): Dose B2, Part B (MAD): Dose B3, Part B (MAD): Dose B4 |
| Placebo (SAD)Single dose of matching placebo; soft capsules for oral use. | Drug | Part A (SAD): Dose A1, Part A (SAD): Dose A2, Part A (SAD): Dose A3, Part A (SAD): Dose A4, Part A (SAD): Dose A5, Part A (SAD): Dose A6 |
| Placebo (MAD)Multiple doses of matching placebo; soft capsules for oral use. | Drug | Part B (MAD): Dose B1, Part B (MAD): Dose B2, Part B (MAD): Dose B3, Part B (MAD): Dose B4 |
| 14C-ACT-1014-6470 microtracerSingle dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use. | Drug | Part A (SAD): Dose A4 |
| 14C-ACT-1014-6470 microtracer placeboSingle dose of matching placebo; soft capsules for oral use. | Drug | Part A (SAD): Dose A4 |
Primary outcome
All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf)
Time frame: Total duration of assessments: up to 3 weeks.
Blood samples for determination of PK parameters will be collected at predefined time points from Day 1 to Day 4 of Part A (SAD, Day 1 to Day 8 for ADME cohort A4) and from Day 1 to Day X+3 of Part B (MAD, with Day X = day of last study treatment administration).
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 12 Aug 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.
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-1014-6470 (SAD), ACT-1014-6470 (MAD) and 14C-ACT-1014-6470 microtracer 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 5 inclusion and 3 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 12 Aug 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 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?
All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf) (time frame: Total duration of assessments: up to 3 weeks.). 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 12 Aug 2020.