Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-451840 in Healthy Subjects (Part A)

The primary objective of the study was to evaluate the safety and tolerability of ACT-451840 in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK) of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

OPTIMED Clinical Research

Gières, 38610, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed informed consent in the local language prior to any study-mandated procedure.
Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at screening.
Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive), measured on the dominant arm, after 5 min in the supine position at screening.
12-lead electrocardiogram without clinically relevant abnormalities, measured after 5 min in the supine position at screening.
Hematology, coagulation, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
No clinically significant findings on the physical examination 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.
Subject covered by Health Insurance system and/or in compliance with the recommendations of the National Law in force relating to biomedical research.
If the subject's partner could become pregnant, reliable methods of contraception must be used from the time of the first administration of study medication until 3 months following administration of the last dose of study medication.

Exclusion criteria

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.
Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
Documented history of chronic liver or gall bladder disease.
Documented history of hemolytic anemia.
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 the 12 months prior to screening.
Subject in the exclusion period of a previous clinical study.
Subject who had received more than 4,500 Euros as indemnities for his participation in a biomedical research within the 12 last months, including the indemnities for the present study.
History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
Excessive caffeine consumption, defined as 800 mg or more per day at screening.
Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study.
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 (hepatitis B and C) serology, except for vaccinated subjects.
Positive results from 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.