Healthy SubjectsPhase 1NCT02719197
First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders
A Phase 1 study testing AC-083 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 male adults 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?
- AC-083
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 19 Feb 2016to 1 Dec 2016
- 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
- Healthy on the basis of physical examination, electrocardiogram and laboratory tests.
- A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake
- Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -1.
- Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.
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 cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations
- 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, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Male 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 male adults
- Conditions
- Healthy Subjects
- Being tested
- AC-083, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-083Drug
Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg
PlaceboDrug
Placebo capsules matching AC-083 capsules
| Study group | Role | What they receive |
|---|---|---|
| AC-083, Single Ascending Dose | Experimental | AC-083 administered at different single dose levels in a sequential manner, and in a maximum of 9 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo) Receives: Drug: AC-083 |
| Placebo, Single Ascending Dose | Placebo comparator | Matched placebo administered as single ascending doses in parallel to AC-083 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 AEs and treatment emergent serious AEs
Measured: From baseline to end of study (EOS) (up to Day 12)
Changes from baseline in supine blood pressure
Supine blood pressure (mmHg)
Measured: From baseline to EOS (up to Day 12)
Changes from baseline in electrocardiogram (ECG) variables
ECG variables are to be recorded at rest using a standard 12-lead ECG
Measured: From baseline to EOS (up to Day 12)
Changes from baseline in pulse rate
Pulse rate (bpm)
Measured: From baseline to EOS (up to Day 12)
Secondary outcomes (4)
Maximum plasma concentration (Cmax) following single oral ascending doses
Cmax is derived from the observed plasma concentration-time curves
Measured: From pre-dose on Day 1 to up to Day 12
Time to reach Cmax (tmax) following single oral ascending doses
Tmax is derived from the observed plasma concentration-time curves
Measured: From pre-dose on Day 1 to up to Day 12
Terminal half-life [t(1/2)] following single oral ascending doses
Measured: From pre-dose on Day 1 to up to Day 12
Area under the plasma concentration-time curve (AUC) following single oral ascending doses
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification, from zero to infinity and from zero to 24 h after study drug administration
Measured: From pre-dose on Day 1 to up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start19 Feb 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 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
- NCT02719197
- Sponsor's protocol ID
- AC-083-101
- Other IDs
- 2015-005012-15, 2015
- Status last verified
- Jul 2018
- First submitted
- 14 Mar 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02719197
- Acronym / sponsor ID
- AC-083-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 25 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 male adults
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC-083, Single Ascending Dose | Experimental | Drug: AC-083AC-083 administered at different single dose levels in a sequential manner, and in a maximum of 9 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo) |
| Placebo, Single Ascending Dose | Placebo comparator | Drug: PlaceboMatched placebo administered as single ascending doses in parallel to AC-083 |
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
- Healthy on the basis of physical examination, electrocardiogram and laboratory tests.
- A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake
- Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -1.
- Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.
Key exclusion criteria (4 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 cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations
- 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-083Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg | Drug | AC-083, Single Ascending Dose |
| PlaceboPlacebo capsules matching AC-083 capsules | Drug | Placebo, Single Ascending Dose |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: From baseline to end of study (EOS) (up to Day 12)
Treatment-emergent AEs and treatment emergent serious AEs
Changes from baseline in supine blood pressure
Time frame: From baseline to EOS (up to Day 12)
Supine blood pressure (mmHg)
Changes from baseline in electrocardiogram (ECG) variables
Time frame: From baseline to EOS (up to Day 12)
ECG variables are to be recorded at rest using a standard 12-lead ECG
Changes from baseline in pulse rate
Time frame: From baseline to EOS (up to Day 12)
Pulse rate (bpm)
4 secondary outcomes
Maximum plasma concentration (Cmax) following single oral ascending doses
Time frame: From pre-dose on Day 1 to up to Day 12
Time to reach Cmax (tmax) following single oral ascending doses
Time frame: From pre-dose on Day 1 to up to Day 12
Terminal half-life [t(1/2)] following single oral ascending doses
Time frame: From pre-dose on Day 1 to up to Day 12
Area under the plasma concentration-time curve (AUC) following single oral ascending doses
Time frame: From pre-dose on Day 1 to up to Day 12
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.
- 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 AC-083 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 5 inclusion and 4 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: From baseline to end of study (EOS) (up to Day 12)). The study lists 4 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.