Status:
COMPLETED
Clinical Study to Assess the Pharmacokinetics, Safety, and Tolerability of ACT-129968 in Healthy Subjects
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To explore the pharmacokinetics (PK) of a single dose of two different formulations of ACT-129968, i.e., tablet versus capsule and to evaluate the safety and tolerability of a single dose of two diffe...
Detailed Description
A total of 10 female and 10 male healthy subjects will be enrolled and will attend two treatment periods, separated by a 7-9 day washout. Over these two periods, two formulations of ACT-129968 (Treatm...
Eligibility Criteria
Inclusion
- Signed informed consent in the local language prior to any study-mandated procedure.
- Women must have
- a negative serum pregnancy test at screening and
- a negative urine pregnancy test pre-dose on Day-1 of each treatment period.
- Women of childbearing potential must consistently and correctly use (from screening, during the entire study, and for at least 28 days after last study drug intake) a reliable method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner.
- Women not of childbearing potential are defined as post-menopausal (i.e., spontaneous amenorrhea for at least 1 year without an alternative medical cause) or surgically or naturally sterile.
- No clinically significant findings on the physical examination at screening.
- Body mass index (BMI) of 18.0 to 28.0 kg/m\^2 (inclusive) at screening.
- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive), measured on the dominant arm (dominant arm = writing arm) after 5 minutes in the supine position at screening.
- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 minutes in the supine position at screening.
- Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
- Negative results from urine drug screen and breath alcohol test at screening and on admission to the unit (Day-1) in Period 1 and Period 2.
- Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
Exclusion
- Pregnant or lactating women.
- Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s).
- 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 drug (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- History or clinical evidence of allergic rhinitis or asthma.
- Veins unsuitable for intravenous 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).
- Previous exposure to the study medication.
- Treatment with another investigational drug within 3 months prior to screening or participation 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.
- Excessive caffeine consumption, defined as 800 mg per day at screening.
- Alcohol consumption of \> 21 units/week or \> 3 units/day.
- Smoking within 3 months prior to screening.
- Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St John's Wort) within 2 weeks prior to first study drug administration.
- Loss of 250 mL or more of blood within 3 months prior to screening.
- Positive results from the hepatitis serology (Hepatitis B surface antigen and anti-hepatitis C virus), except for vaccinated subjects or subjects with past but resolved hepatitis (defined as positive finding for antibodies but negative findings for antigens), at screening.
- Positive results from the human immunodeficiency virus serology at screening.
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01877629
Start Date
July 1 2011
End Date
July 1 2011
Last Update
July 10 2018
Active Locations (1)
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1
PHAROS GmbH Clinical Research
Ulm, Germany, D-89081