- To evaluate the safety and tolerability of ascending single oral doses of ACT-462206 in healthy male subjects.- To investigate the single oral dose PK and PD of ACT-462206 in healthy male subjects.- To investigate dose proportionality across…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety:
- Vital signs (heart rate, blood pressure) and body weight
- ECG variables
- Changes in blood- and urine tests
- Occurence of (serious) adverse events
Pharmacokinetics:
- Cmax, Tmax, t1/2
- AUC
- dose-proportionality
Pharmacodynamics:
- Saccadic peak velocity
- Body sway
- Adaptive tracking
- VAS Bond and Lader
Secondary outcome
Pharmacokinetics:
- renal clearance
- percentage of dose excreted unchanged in urine
Background summary
In this study we investigate the effect of a new investigational drug
(ACT-462206) on the body, during this study it will be the first time that it
will be given to humans. The drug is being developed for the treatment of sleep
disturbances and works via orexin. Orexin is a substance that is produced in
the brain and plays a role in the sleep- wake cycle and alertness. ACT-462206,
blocks temporarily the action of orexin. Laboratory animals that have been
administered ACT-462206 fell asleep after taking it, but cou ld easily wake up
(in contrast to other sleep medications) and then function normally.
Study objective
- To evaluate the safety and tolerability of ascending single oral doses of
ACT-462206 in healthy male subjects.
- To investigate the single oral dose PK and PD of ACT-462206 in healthy male
subjects.
- To investigate dose proportionality across different doses of ACT-462206.
Study design
Double-blind, placebo and active-controlled, randomised study with
single-ascending doses.
Intervention
Single dose of ACT-462206, almorexant, or placebo.
Study burden and risks
The side-effects that are expected for ACT-462206 and Almorexant are associated
with its sleep-promoting potential and consist of somnolence, dizziness,
fatigue and reduced vigilance.
Gewerbestrasse 16
CH-4123 Allschwil
CH
Gewerbestrasse 16
CH-4123 Allschwil
CH
Listed location countries
Age
Inclusion criteria
- Signed informed consent prior to any study-mandated procedure.;- Healthy male subjects aged between 18 and 45 years (inclusive) at screening.;- Hematology, clinical chemistry, and urinalysis results not deviating from the normal range to a clinically relevant extent at screening.;- No clinically significant findings on physical examination at screening.;- Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening.;- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 bpm (inclusive) measured at screening on the dominant arm after 5 minutes in supine position.;- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities in supine position at screening.;- Negative results from urine drug screen at screening.;- Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
Exclusion criteria
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.;- Veins unsuitable for intravenous (i.v.) puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).;- Treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort) within 2 weeks prior to (first) study drug administration.;- Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.;- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.;- 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 drugs.;- Excessive caffeine consumption, defined as >= 800 mg per day at screening.;- Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study (from screening to End-of-Study [EOS]).;- Loss of 250 mL or more of blood, or an equivalent amount of plasma, within 3 months prior to screening.;- Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening.;- Positive results from the HIV serology at screening.;- Known hypersensitivity to any excipients of the drug formulations.;- Modified Swiss Narcolepsy Scale total score < 0 or history of narcolepsy or cataplexy. ;- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.;- Legal incapacity or limited legal capacity at screening.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
EudraCT | EUCTR2011-003752-39-NL |
CCMO | NL38094.056.11 |