Healthy SubjectsPhase 1NCT02571855
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects
A Phase 1 study testing ACT-541468 (hydrochloride salt) and ACT-541468 (free base) in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of ACT-541468 following multiple ascending doses in healthy adults and following single ascending doses in healthy elderly subjects when… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ACT-541468 (hydrochloride salt) and ACT-541468 (free base)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2015to 1 Feb 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Adults aged from 18 to 45 years (inclusive) for Part A; elderly aged from 65 to 80 years (inclusive) for Part B; both adults from 18 to 45 years and elderly from 65 to 80 years (inclusive) for Part C.
- Regular sleep pattern of at least 6 hours nocturnal sleep.
- Young females must have negative pregnancy tests at screening and at pre-dose on Day 1 and use a reliable method of contraception
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
- Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 100-145 mmHg, 50-90 mmHg and 45-90 bpm (all inclusive) for young adults, respectively; SBP, DBP and PR between 100-160 mmHg, 50-95 mmHg and 45-100 bpm (all inclusive) for elderly, respectively.
- Healthy on the basis of physical examination,electrocardiogram and laboratory tests.
Who cannot join
- Principal exclusion criteria common to young adults and elderly:
- Pregnant or lactating women.
- Any contraindication to the study drugs.
- History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs.
- History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0 at screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
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- Treatment with any prescribed medications or over-the-counter medications within 2 weeks prior to study drug administration.
- Previous chronic treatment with any medication that is not given in stable doses and/or stable regimen within 2 months prior to screening.
- Previous treatment with CNS-active drugs or within 2 months prior to screening.
- Treatment with inhibitors of CYP3A4 (e.g., azole derivatives, ritonavir, clarithromycin) from 2 weeks prior to screening visit and up to EOS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-541468: Part A: Multiple-ascending Doses in Healthy Young Adults After Morning Administration Part B: Single-ascending Doses in Healthy Elderly Subjects After Morning Administration Part C: Repeated Doses in Both Healthy Young Adults and Elderly Subjects After Evening Administration
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of ACT-541468 following multiple ascending doses in healthy adults and following single ascending doses in healthy elderly subjects when administered in the morning. The safety, PK and PD of ACT-541468 will also be assessed after repeated evening administration of a selected dose in both healthy adults and elderly.
Read the detailed description
In the first-in-man study, single doses of ACT-541468 administered in healthy young adults were well tolerated up to the dose level of 200 mg (inclusive) and yielded results compatible with possible sleep facilitating effects of ACT-541468. So the present study aimed to further investigate the effects of ACT-541468 after multiple ascending doses in healthy young subjects as well as after single ascending doses in elderly subjects (morning administrations). The effects of repeated administrations of a selected dose administered in the evening in both healthy adults and elderly, will also be investigated.
- Conditions
- Healthy Subjects
- Being tested
- ACT-541468 (hydrochloride salt), ACT-541468 (free base), Placebo
- Keywords
- insomnia, Pharmacokinetics, Safety, Pharmacodynamics, Healthy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-541468 (hydrochloride salt)Drug
Hard-gelatin capsules (strength: 5 mg and 25 mg)
ACT-541468 (free base)Drug
Soft capsules (strength: 25 mg)
PlaceboDrug
Placebo capsules matching the ACT-541468 formulations
| Study group | Role | What they receive |
|---|---|---|
| Part A: ACT-541468 multiple ascending doses | Experimental | Six young adults will receive ACT-541468 in the morning from Day 1 to Day 5 at each dose level in a sequential manner (total number of subjects = 18). Planned dose levels are 10, 25 and 75 mg per day Receives: Drug: ACT-541468 (hydrochloride salt) |
| Part A: Placebo | Placebo comparator | For each ACT-541468 dose level tested in Part A, 2 young adults will receive matching placebo in the same conditions (total number of subjects = 6) Receives: Drug: Placebo |
| Part B: ACT-541468 single ascending doses | Experimental | Six elderly will receive ACT-541468 in the morning of Day 1 at each dose level in a sequential manner (total number of subjects = 18). Planned dose levels are 5, 15 and 25 mg Receives: Drug: ACT-541468 (hydrochloride salt) |
| Part B: Placebo | Placebo comparator | For each ACT-541468 dose level tested in Part B, 2 elderly will receive matching placebo in the same conditions (total number of subjects = 6) Receives: Drug: Placebo |
| Part C: repeated dose of ACT-541468 | Experimental | Sixteen young adults and eight elderly will receive ACT-541468 (planned dose: 25 mg) in the evening for 7 days (8 days for 6 of the 16 young adults). Receives: Drug: ACT-541468 (free base) |
| Part C: Placebo | Placebo comparator | Four young adults and 2 elderly will receive matching placebo in the same conditions as subjects receiving the active compound in Part C 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 will be evaluated throughout the study
Measured: up to 72 hours post dosing
Changes from baseline in ECG variables and vital signs (heart rate and blood pressure)
12-lead electrocardiogram variables including RR, PR, QRS, QT and QTc intervals at scheduled time points during Parts A, B and C
Measured: up to 72 hours post dosing
Changes from baseline in clinical laboratory parameters
Laboratory tests including hematology, blood chemistry and urinalysis at scheduled time points during PArts A, B and C
Measured: up to 72 hours post dosing
Secondary outcomes (9)
Maximum plasma concentration (Cmax) of ACT-541468 after daytime and bedtime intake
Cmax will be determined after single (Parts A and B) and multiple morning doses (Part A) as well as after repeated evening doses to identify the nighttime PK profile (Part C)
Measured: Part A: Day 1 and Day 5; Part B: Day 1; Part C: evening of Day 8 (pre-dose) and Day 9 (nighttime samples)
Time to reach Cmax (tmax) of ACT-541468 after daytime and bedtime intake
tmax will be determined after single (Parts A and B) and multiple morning doses (Part A) as well as after repeated evening doses to identify the nighttime PK profile (Part C)
Measured: Part A: Day 1 and Day 5; Part B: Day 1; Part C: evening of Day 8 (pre-dose) and Day 9 (nighttime samples)
Terminal half-life [t(1/2)] after daytime and bedtime intake
t(1/2) will be determined after single (Parts A and B) and multiple morning doses (Part A) as well as after repeated evening doses (Part C)
Measured: Part A: Days 1 and 5, from pre-dose up to 72 h post-dose; Part B: Day 1, at pre-dose up to 72 h post-dose; Part C: from the morning of Day 8 up to 60 h post-dose and from the evening of Day 8 (pre-dose) until 36 h post-dose (with nighttime samples)
Areas under the plasma concentration-time curves [AUC(0-8), AUC(0-24)] of ACT-541468 after daytime and bedtime intake
AUC from time 0 to 8 hours after study drug administration [AUC(0--8)] and from time 0 to 24 hours after study drug administration [AUC(0--24)] will be determined after single (parts A and B) and multiple morning doses (Part A) as well as after multiple evening doses (Part C)
Measured: Part A: Days 1 and 5, from pre-dose up to 72 h post-dose; Part B: Day 1, at pre-dose up to 72 h post-dose; Part C: from the morning of Day 8 up to 60 h post-dose and from the evening of Day 8 (pre-dose) until 36 h post-dose (with nighttime samples)
Areas under the plasma concentration-time curves [AUC(0-t), AUC(0-inf)] of ACT-541468 after daytime and bedtime intake
AUC from time 0 to infinity [AUC(0--inf], AUC from time 0 to time of the last measured concentration above the limit of quantification [AUC(0--t)] will be determined after single (Part B) and multiple morning doses (Part A) as well as after multiple evening doses (Part C)
Measured: Part A: Day 5, from pre-dose up to 72 h post-dose; Part B: Day 1, at pre-dose up to 72 h post-dose; Part C: from the morning of Day 8 up to 60 h post-dose and from the evening of Day 8 (pre-dose) until 36 h post-dose (with nighttime samples)
Sedation as measured by saccadic peak velocity
saccadic eye movements (SEM) will be recorded by electrooculography and the average values of saccadic peak velocity of the SEM will be used as parameter of sedation
Measured: Part A: Day 1 and Day 5; Part B: Day 1; Part C: Day 2 and Day 14
Visual motor coordination
Visual motor coordination will be assessed with the adaptive tracking test and the average tracking performance will be used as parameter of coordination
Measured: Part A: Day 1 and Day 5; Part B: Day 1; Part C: Day 2 and Day 14
Change from baseline in body sway
Body sway will be assessed using a body sway meter
Measured: Part A: Day 1 and Day 5; Part B: Day 1; Part C: Day 2 and Day 14
Change from baseline in subjective cognitive effects
Subjects will rate sleepiness, alertness and mood using questionnaires
Measured: Part A: every day from Day 1 to Day 6; Part B: Day 1; Part C: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Feb 2016
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clemens Mühlan, MSc, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571855
- Sponsor's protocol ID
- AC-078-102
- Status last verified
- Jul 2018
- First submitted
- 2 Oct 2015
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Muehlan C, Boehler M, Brooks S, Zuiker R, van Gerven J, Dingemanse J. Clinical pharmacology of the dual orexin receptor antagonist ACT-541468 in elderly subjects: Exploration of pharmacokinetics, pharmacodynamics and tolerability following single-dose morning and repeated-dose evening administration. J Psychopharmacol. 2020 Mar;34(3):326-335. doi: 10.1177/0269881119882854. Epub 2019 Oct 23.
PubMed 31642731
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
- Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-541468: Part A: Multiple-ascending Doses in Healthy Young Adults After Morning Administration Part B: Single-ascending Doses in Healthy Elderly Subjects After Morning Administration Part C: Repeated Doses in Both Healthy Young Adults and Elderly Subjects After Evening Administration
- ClinicalTrials.gov ID
- NCT02571855
- Acronym / sponsor ID
- AC-078-102
- Conditions
- Healthy Subjects
- Keywords
- insomnia, Pharmacokinetics, Safety, Pharmacodynamics, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 8 Oct 2015 (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 purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of ACT-541468 following multiple ascending doses in healthy adults and following single ascending doses in healthy elderly subjects when administered in the morning. The safety, PK and PD of ACT-541468 will also be assessed after repeated evening administration of a selected dose in both healthy adults and elderly.
Detailed description
In the first-in-man study, single doses of ACT-541468 administered in healthy young adults were well tolerated up to the dose level of 200 mg (inclusive) and yielded results compatible with possible sleep facilitating effects of ACT-541468. So the present study aimed to further investigate the effects of ACT-541468 after multiple ascending doses in healthy young subjects as well as after single ascending doses in elderly subjects (morning administrations). The effects of repeated administrations of a selected dose administered in the evening in both healthy adults and elderly, will also be investigated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: ACT-541468 multiple ascending doses | Experimental | Drug: ACT-541468 (hydrochloride salt)Six young adults will receive ACT-541468 in the morning from Day 1 to Day 5 at each dose level in a sequential manner (total number of subjects = 18). Planned dose levels are 10, 25 and 75 mg per day |
| Part A: Placebo | Placebo comparator | Drug: PlaceboFor each ACT-541468 dose level tested in Part A, 2 young adults will receive matching placebo in the same conditions (total number of subjects = 6) |
| Part B: ACT-541468 single ascending doses | Experimental | Drug: ACT-541468 (hydrochloride salt)Six elderly will receive ACT-541468 in the morning of Day 1 at each dose level in a sequential manner (total number of subjects = 18). Planned dose levels are 5, 15 and 25 mg |
| Part B: Placebo | Placebo comparator | Drug: PlaceboFor each ACT-541468 dose level tested in Part B, 2 elderly will receive matching placebo in the same conditions (total number of subjects = 6) |
| Part C: repeated dose of ACT-541468 | Experimental | Drug: ACT-541468 (free base)Sixteen young adults and eight elderly will receive ACT-541468 (planned dose: 25 mg) in the evening for 7 days (8 days for 6 of the 16 young adults). |
| Part C: Placebo | Placebo comparator | Drug: PlaceboFour young adults and 2 elderly will receive matching placebo in the same conditions as subjects receiving the active compound in Part C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent.
- Adults aged from 18 to 45 years (inclusive) for Part A; elderly aged from 65 to 80 years (inclusive) for Part B; both adults from 18 to 45 years and elderly from 65 to 80 years (inclusive) for Part C.
- Regular sleep pattern of at least 6 hours nocturnal sleep.
- Young females must have negative pregnancy tests at screening and at pre-dose on Day 1 and use a reliable method of contraception
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- Any contraindication to the study drugs.
- History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs.
- History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0 at screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's 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 |
|---|---|---|
| ACT-541468 (hydrochloride salt)Hard-gelatin capsules (strength: 5 mg and 25 mg) | Drug | Part A: ACT-541468 multiple ascending doses, Part B: ACT-541468 single ascending doses |
| ACT-541468 (free base)Soft capsules (strength: 25 mg) | Drug | Part C: repeated dose of ACT-541468 |
| PlaceboPlacebo capsules matching the ACT-541468 formulations | Drug | Part A: Placebo, Part B: Placebo, Part C: Placebo |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: up to 72 hours post dosing
Treatment emergent adverse events and treatment emergent serious adverse events will be evaluated throughout the study
Changes from baseline in ECG variables and vital signs (heart rate and blood pressure)
Time frame: up to 72 hours post dosing
12-lead electrocardiogram variables including RR, PR, QRS, QT and QTc intervals at scheduled time points during Parts A, B and C
Changes from baseline in clinical laboratory parameters
Time frame: up to 72 hours post dosing
Laboratory tests including hematology, blood chemistry and urinalysis at scheduled time points during PArts A, B and C
9 secondary outcomes
Maximum plasma concentration (Cmax) of ACT-541468 after daytime and bedtime intake
Time frame: Part A: Day 1 and Day 5; Part B: Day 1; Part C: evening of Day 8 (pre-dose) and Day 9 (nighttime samples)
Time to reach Cmax (tmax) of ACT-541468 after daytime and bedtime intake
Time frame: Part A: Day 1 and Day 5; Part B: Day 1; Part C: evening of Day 8 (pre-dose) and Day 9 (nighttime samples)
Terminal half-life [t(1/2)] after daytime and bedtime intake
Time frame: Part A: Days 1 and 5, from pre-dose up to 72 h post-dose; Part B: Day 1, at pre-dose up to 72 h post-dose; Part C: from the morning of Day 8 up to 60 h post-dose and from the evening of Day 8 (pre-dose) until 36 h post-dose (with nighttime samples)
Areas under the plasma concentration-time curves [AUC(0-8), AUC(0-24)] of ACT-541468 after daytime and bedtime intake
Time frame: Part A: Days 1 and 5, from pre-dose up to 72 h post-dose; Part B: Day 1, at pre-dose up to 72 h post-dose; Part C: from the morning of Day 8 up to 60 h post-dose and from the evening of Day 8 (pre-dose) until 36 h post-dose (with nighttime samples)
Areas under the plasma concentration-time curves [AUC(0-t), AUC(0-inf)] of ACT-541468 after daytime and bedtime intake
Time frame: Part A: Day 5, from pre-dose up to 72 h post-dose; Part B: Day 1, at pre-dose up to 72 h post-dose; Part C: from the morning of Day 8 up to 60 h post-dose and from the evening of Day 8 (pre-dose) until 36 h post-dose (with nighttime samples)
Sedation as measured by saccadic peak velocity
Time frame: Part A: Day 1 and Day 5; Part B: Day 1; Part C: Day 2 and Day 14
Visual motor coordination
Time frame: Part A: Day 1 and Day 5; Part B: Day 1; Part C: Day 2 and Day 14
Change from baseline in body sway
Time frame: Part A: Day 1 and Day 5; Part B: Day 1; Part C: Day 2 and Day 14
Change from baseline in subjective cognitive effects
Time frame: Part A: every day from Day 1 to Day 6; Part B: Day 1; Part C: Day 1 to Day 8
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.
- Derived from this study: PubMed 31642731Muehlan C, Boehler M, Brooks S, Zuiker R, van Gerven J, Dingemanse J. Clinical pharmacology of the dual orexin receptor antagonist ACT-541468 in elderly subjects: Exploration of pharmacokinetics, pharmacodynamics and tolerability following single-dose morning and repeated-dose evening administration. J Psychopharmacol. 2020 Mar;34(3):326-335. doi: 10.1177/0269881119882854. Epub 2019 Oct 23.
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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.
Clemens Mühlan, MSc 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 ACT-541468 (hydrochloride salt) and ACT-541468 (free base) in people with Healthy Subjects, 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 7 inclusion and 10 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 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. 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 72 hours post dosing). 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?
On the ClinicalTrials.gov record for NCT02571855, which also lists 1 linked publication.
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.