A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-02-01

Brief Summary

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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.

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Detailed Description

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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

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: ACT-541468 multiple ascending doses

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

Group Type EXPERIMENTAL

ACT-541468 (hydrochloride salt)

Intervention Type DRUG

Hard-gelatin capsules (strength: 5 mg and 25 mg)

Part A: Placebo

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules matching the ACT-541468 formulations

Part B: ACT-541468 single ascending doses

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

Group Type EXPERIMENTAL

ACT-541468 (hydrochloride salt)

Intervention Type DRUG

Hard-gelatin capsules (strength: 5 mg and 25 mg)

Part B: Placebo

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules matching the ACT-541468 formulations

Part C: repeated dose of ACT-541468

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).

Group Type EXPERIMENTAL

ACT-541468 (free base)

Intervention Type DRUG

Soft capsules (strength: 25 mg)

Part C: Placebo

Four young adults and 2 elderly will receive matching placebo in the same conditions as subjects receiving the active compound in Part C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules matching the ACT-541468 formulations

Interventions

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ACT-541468 (hydrochloride salt)

Hard-gelatin capsules (strength: 5 mg and 25 mg)

Intervention Type DRUG

ACT-541468 (free base)

Soft capsules (strength: 25 mg)

Intervention Type DRUG

Placebo

Placebo capsules matching the ACT-541468 formulations

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes