Healthy SubjectsPhase 1NCT02905253

A Study to Evaluate if AC-084 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

A Phase 1 study testing AC-084 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: AC-084
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited Kingdom
Study dates: 12 Sep 2016to 10 Dec 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Signed informed consent in the local language prior to any study-mandated procedure
Healthy male subjects for Part A, healthy male and female subjects for Part B and Part C aged between 18 and 55 years (inclusive) at screening
No clinically significant findings on physical examination at screening
Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at screening
CYP2C9 poor metabolizers (Part C)

Who cannot join

History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
Treatment or substances known to induce CYP enzyme drug metabolism within 30 days prior to first study treatment administration
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of their excipients
For Part A and Part B, CYP2C9 poor metabolizers enrolled in a cohort to be dosed with single or multiple dose of 500 mg or higher of ACT-774312 (confirmed by genotyping before enrollment)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A Three-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of AC-084 in Healthy Subjects and to Investigate the Pharmacokinetics of a Single Dose of AC-084 in Healthy CYP2C9 Poor Metabolizers

The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults

Read the detailed description

The study is designed in three parts, A, B and C

Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose

Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose

Part C: single-center, open-label, single dose in CYP2C9 poor metabolizers

Conditions: Healthy Subjects
Being tested: AC-084, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AC-084Drug
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
PlaceboDrug
Placebo capsules matching AC-084 capsules

Study groups in NCT02905253
Study group	Role	What they receive
AC-084, single ascending dose (Part A)	Experimental	AC-084 administered at different single dose levels in a sequential manner, and in a maximum of 7 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 at least 8 healthy male subjects (6 on active drug and 2 on placebo) Receives: Drug: AC-084
Placebo,single ascending dose (Part A)	Placebo comparator	Matched placebo administered as single ascending doses in parallel to AC-084 Receives: Drug: Placebo
AC-084, multiple ascending dose (Part B)	Experimental	AC-084 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be between 1 and 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A. Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo) Receives: Drug: AC-084
Placebo,multiple ascending dose (Part B)	Placebo comparator	Matched placebo administered as multiple ascending doses in parallel to AC-084 Receives: Drug: Placebo
AC-084, single dose (Part C)	Experimental	Up to 6 subjects in part C will receive AC-084 administered at a single dose (foreseen to be 100 mg) Receives: Drug: AC-084

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events (AEs) (Part A)
Treatment-emergent AEs and treatment-emergent serious AEs
Measured: From dosing until day 4
Number of participants with adverse events (AEs) (Part B)
Treatment-emergent AEs and treatment-emergent serious AEs
Measured: From dosing until day 8
Number of participants with adverse events (AEs) (Part C)
Treatment-emergent AEs and treatment-emergent serious AEs
Measured: From dosing until day 6
Incidence of safety events of interest (Part A)
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
Measured: From dosing until day 4
Incidence of safety events of interest (Part B)
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
Measured: From dosing until day 8
Incidence of safety events of interest (Part C)
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
Measured: From dosing until day 6

Secondary outcomes (12)

Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)
Cmax is derived from the observed plasma concentration-time curves
Measured: From dosing until day 4
Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)
Cmax is derived from the observed plasma concentration-time curves
Measured: From dosing until day 8
Maximum plasma concentration (Cmax) following single oral ascending doses (Part C)
Cmax is derived from the observed plasma concentration-time curves
Measured: From dosing until day 6
Time to reach Cmax (tmax) following single oral ascending doses (Part A)
Tmax is derived from the observed plasma concentration-time curves
Measured: From dosing until day 4
Time to reach Cmax (tmax) following single oral ascending doses (Part B)
Tmax is derived from the observed plasma concentration-time curves
Measured: From dosing until day 8
Time to reach Cmax (tmax) following single oral ascending doses (Part C)
Tmax is derived from the observed plasma concentration-time curves
Measured: From dosing until day 6
Terminal half-life [t(1/2)] following single oral ascending doses (Part A)
Measured: From dosing until day 4
Terminal half-life [t(1/2)] following single oral ascending doses (Part B)
Measured: From dosing until day 8
Terminal half-life [t(1/2)] following single oral ascending doses (Part C)
Measured: From dosing until day 6
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A)
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Measured: From dosing until day 4
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B)
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Measured: From dosing until day 8
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C)
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Measured: From dosing until day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 201610 Dec 2017

First posted19 Sep 2016 (estimated)
Study start12 Sep 2016
Primary completion10 Dec 2017
Study completion10 Dec 2017

Why it stopped: The study has been terminated due to difficulties in recruiting subjects into Part C. No safety concerns contributed to the termination of the study

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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02905253
Sponsor's protocol ID: AC-084-101
Status last verified: Jul 2018
First submitted: 31 Aug 2016
Last updated: 10 Jul 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Subjects trials

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: A Three-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of AC-084 in Healthy Subjects and to Investigate the Pharmacokinetics of a Single Dose of AC-084 in Healthy CYP2C9 Poor Metabolizers
ClinicalTrials.gov ID: NCT02905253
Acronym / sponsor ID: AC-084-101
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study has been terminated due to difficulties in recruiting subjects into Part C. No safety concerns contributed to the termination of the study
Enrolment: 56 participants (actual)
Lead sponsor: Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 12 Sep 2016 (actual)
Primary completion: 10 Dec 2017 (actual)
Study completion: 10 Dec 2017 (actual)
First posted: 19 Sep 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 AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults

Detailed description

The study is designed in three parts, A, B and C

Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose

Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose

Part C: single-center, open-label, single dose in CYP2C9 poor metabolizers

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
AC-084, single ascending dose (Part A)	Experimental	Drug: AC-084AC-084 administered at different single dose levels in a sequential manner, and in a maximum of 7 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 at least 8 healthy male subjects (6 on active drug and 2 on placebo)
Placebo,single ascending dose (Part A)	Placebo comparator	Drug: PlaceboMatched placebo administered as single ascending doses in parallel to AC-084
AC-084, multiple ascending dose (Part B)	Experimental	Drug: AC-084AC-084 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be between 1 and 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A. Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo)
Placebo,multiple ascending dose (Part B)	Placebo comparator	Drug: PlaceboMatched placebo administered as multiple ascending doses in parallel to AC-084
AC-084, single dose (Part C)	Experimental	Drug: AC-084Up to 6 subjects in part C will receive AC-084 administered at a single dose (foreseen to be 100 mg)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Signed informed consent in the local language prior to any study-mandated procedure
Healthy male subjects for Part A, healthy male and female subjects for Part B and Part C aged between 18 and 55 years (inclusive) at screening
No clinically significant findings on physical examination at screening
Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at screening
CYP2C9 poor metabolizers (Part C)

Key exclusion criteria (6 listed)

History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
Treatment or substances known to induce CYP enzyme drug metabolism within 30 days prior to first study treatment administration
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of their excipients

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-084Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg	Drug	AC-084, multiple ascending dose (Part B), AC-084, single ascending dose (Part A), AC-084, single dose (Part C)
PlaceboPlacebo capsules matching AC-084 capsules	Drug	Placebo,multiple ascending dose (Part B), Placebo,single ascending dose (Part A)

Primary outcome

Number of participants with adverse events (AEs) (Part A)
Time frame: From dosing until day 4
Treatment-emergent AEs and treatment-emergent serious AEs
Number of participants with adverse events (AEs) (Part B)
Time frame: From dosing until day 8
Treatment-emergent AEs and treatment-emergent serious AEs
Number of participants with adverse events (AEs) (Part C)
Time frame: From dosing until day 6
Treatment-emergent AEs and treatment-emergent serious AEs
Incidence of safety events of interest (Part A)
Time frame: From dosing until day 4
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
Incidence of safety events of interest (Part B)
Time frame: From dosing until day 8
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
Incidence of safety events of interest (Part C)
Time frame: From dosing until day 6
Events of interest are any abnormalities in ECG, vital signs or laboratory test results

12 secondary outcomes

Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)
Time frame: From dosing until day 4
Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)
Time frame: From dosing until day 8
Maximum plasma concentration (Cmax) following single oral ascending doses (Part C)
Time frame: From dosing until day 6
Time to reach Cmax (tmax) following single oral ascending doses (Part A)
Time frame: From dosing until day 4
Time to reach Cmax (tmax) following single oral ascending doses (Part B)
Time frame: From dosing until day 8
Time to reach Cmax (tmax) following single oral ascending doses (Part C)
Time frame: From dosing until day 6
Terminal half-life [t(1/2)] following single oral ascending doses (Part A)
Time frame: From dosing until day 4
Terminal half-life [t(1/2)] following single oral ascending doses (Part B)
Time frame: From dosing until day 8
Terminal half-life [t(1/2)] following single oral ascending doses (Part C)
Time frame: From dosing until day 6
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A)
Time frame: From dosing until day 4
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B)
Time frame: From dosing until day 8
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C)
Time frame: From dosing until day 6

Results and safety

The study was stopped early (reason given: The study has been terminated due to difficulties in recruiting subjects into Part C. No safety concerns contributed to the termination of the study). Results are not available in the source record.

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.

Martine Géhin, 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-084 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in United Kingdom.

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 6 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: stopped early, 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 United Kingdom. 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?

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) (Part A) (time frame: From dosing until day 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02905253.

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.