Healthy SubjectsPhase 1NCT02702648
First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders
A Phase 1 study testing AC-082 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
Trial summary
The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- AC-082
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2016to 6 Mar 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests
- Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive)
- Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1
- Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive)
- Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 90-140 mmHg, 50-90 mmHg and 50-90 bpm (all inclusive), respectively
Who cannot join
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
- Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects
The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults
- Conditions
- Healthy Subjects
- Being tested
- AC-082, Placebo
- Keywords
- healthy subjects, first-in-man, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-082Drug
Hard gelatin capsules for oral administration
PlaceboDrug
Matched placebo capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| AC-082, Single Ascending Dose | Experimental | Subjects receive AC-082 at different single dose levels in a sequential manner, starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each subject can participate in only one dose level Receives: Drug: AC-082 |
| Placebo, Single Ascending Dose | Placebo comparator | Subjects receive a single dose of the matched placebo Receives: Drug: Placebo |
| AC-082, Multiple Ascending Dose | Experimental | Subjects receive AC-082 at different dose levels for 4 consecutive days in a sequential manner (dose levels and duration to be adapted according to the results of the single ascending dose cohorts). Each subject can participate in only one dose level Receives: Drug: AC-082 |
| Placebo, Multiple Ascending Dose | Placebo comparator | Subjects receive the matched placebo for 4 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Treatment-emergent adverse events and treatment-emergent serious adverse events
Measured: Up to end of study (up to Day 11)
Changes from baseline in vital signs
Vital signs include diastolic and systolic blood pressure and pulse rate
Measured: Up to end of study (up to Day 11)
Changes from baseline in ECG variables
ECG variables are to be recorded at rest using a standard 12-lead ECG
Measured: Up to end of study (up to day 11)
Secondary outcomes (8)
Maximum plasma concentration (Cmax) following single ascending doses
Cmax is derived from the observed plasma concentration-time curves
Measured: From pre-dose on Day 1 to 96 hours post dose
Time to reach Cmax (tmax) following single ascending doses
tmax is derived from the observed plasma concentration-time curves
Measured: From pre-dose on Day 1 to 96 hours post dose
Terminal half-life [t(1/2)] following single ascending doses
Measured: From pre-dose on Day 1 to 96 hours post dose
Area under the plasma concentration-time curve (AUC) following single ascending doses
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification [AUC(0-t)] and from zero to infinity [AUC(0-inf)]
Measured: From pre-dose on Day 1 to 96 hours post dose
Maximum plasma concentration (Cmax) following multiple ascending doses
Measured: Up to 96 hours following the last dose administration on Day 4
Time to reach Cmax (tmax) following multiple ascending doses
Measured: Up to 96 hours following the last dose administration on Day 4
Terminal half-life [t(1/2)] following multiple ascending doses
t(1/2) on the last day of dosing
Measured: Up to 96 hours following the last dose administration on Day 4
Area under the plasma concentration-time curve during a dosing interval (AUCtau)
AUCtau is the area under the plasma concentration-time curve during a dosing interval
Measured: Day 1 and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start1 Feb 2016
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karine Litherland, PhD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702648
- Sponsor's protocol ID
- AC-082-101
- Status last verified
- Jul 2018
- First submitted
- 24 Feb 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02702648
- Acronym / sponsor ID
- AC-082-101
- Conditions
- Healthy Subjects
- Keywords
- healthy subjects, first-in-man, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2016
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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.
The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AC-082, Single Ascending Dose | Experimental | Drug: AC-082Subjects receive AC-082 at different single dose levels in a sequential manner, starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each subject can participate in only one dose level |
| Placebo, Single Ascending Dose | Placebo comparator | Drug: PlaceboSubjects receive a single dose of the matched placebo |
| AC-082, Multiple Ascending Dose | Experimental | Drug: AC-082Subjects receive AC-082 at different dose levels for 4 consecutive days in a sequential manner (dose levels and duration to be adapted according to the results of the single ascending dose cohorts). Each subject can participate in only one dose level |
| Placebo, Multiple Ascending Dose | Placebo comparator | Drug: PlaceboSubjects receive the matched placebo for 4 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests
- Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive)
- Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1
- Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive)
Key exclusion criteria (3 listed)
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
- Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol
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 |
|---|---|---|
| AC-082Hard gelatin capsules for oral administration | Drug | AC-082, Multiple Ascending Dose, AC-082, Single Ascending Dose |
| PlaceboMatched placebo capsules for oral administration | Drug | Placebo, Multiple Ascending Dose, Placebo, Single Ascending Dose |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to end of study (up to Day 11)
Treatment-emergent adverse events and treatment-emergent serious adverse events
Changes from baseline in vital signs
Time frame: Up to end of study (up to Day 11)
Vital signs include diastolic and systolic blood pressure and pulse rate
Changes from baseline in ECG variables
Time frame: Up to end of study (up to day 11)
ECG variables are to be recorded at rest using a standard 12-lead ECG
8 secondary outcomes
Maximum plasma concentration (Cmax) following single ascending doses
Time frame: From pre-dose on Day 1 to 96 hours post dose
Time to reach Cmax (tmax) following single ascending doses
Time frame: From pre-dose on Day 1 to 96 hours post dose
Terminal half-life [t(1/2)] following single ascending doses
Time frame: From pre-dose on Day 1 to 96 hours post dose
Area under the plasma concentration-time curve (AUC) following single ascending doses
Time frame: From pre-dose on Day 1 to 96 hours post dose
Maximum plasma concentration (Cmax) following multiple ascending doses
Time frame: Up to 96 hours following the last dose administration on Day 4
Time to reach Cmax (tmax) following multiple ascending doses
Time frame: Up to 96 hours following the last dose administration on Day 4
Terminal half-life [t(1/2)] following multiple ascending doses
Time frame: Up to 96 hours following the last dose administration on Day 4
Area under the plasma concentration-time curve during a dosing interval (AUCtau)
Time frame: Day 1 and 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 10 Jul 2018.
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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.
Karine Litherland, PhD study director
Actelion
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 AC-082 in people with Healthy Subjects, 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 6 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 10 Jul 2018. 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?
Number of participants with adverse events (AEs) (time frame: Up to end of study (up to Day 11)). The study lists 3 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 10 Jul 2018.