Intervention: Emodepside
Trial phase: Phase 1
SMILES: [H][C@]1(C)OC(=O)[C@]([H])(CC(C)C)N(C)C(=O)[C@@]([H])(Cc2ccc(N3CCOCC3)cc2)OC(=O)[C@]([H])(CC(C)C)N(C)C(=O)[C@@]([H])(C)OC(=O)[C@]([H])(CC(C)C)N(C)C(=O)[C@@]([H])(Cc2ccc(N3CCOCC3)cc2)OC(=O)[C@]([H])(CC(C)C)N(C)C1=O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 5 mg emodepside IR-tablet #406, fed

Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
Eligibility criteria:
Inclusion Criteria:

Male, Caucasian volunteers, deemed healthy based on a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine.
18 to 45 years of age
Normal body weight (Body Mass Index (BMI); Quetelet index) in the range 18.0 to 30.1 kg/m2 at screening
Mean blood pressure and heart rate (from the triplicate readings) in the supine position at the screening assessment outside one (or more) of the ranges: 90-140 mm Hg systolic BP 60-90 mm Hg diastolic BP 45-100 beats/min HR
Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire trial
Willingness to give written consent to participate, after reading the information and consent form, and after having the opportunity to discuss the trial with the Investigator or his delegate
Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS)

Willingness to follow contraception requirements of the study, from the first dose of the IMP until 90 days after dosing and inform HMR as soon as possible if their partner becomes pregnant in the 90 days after dosing

Exclusion Criteria:

Administration of a licensed or unlicensed medicinal product as part of another clinical trial in the 3 months before the first dose of study medication, or within 5 half-lives of administration of a medicinal product given in the previous study (whichever is longer), or otherwise in the follow-up period for any clinical trial
Clinically relevant abnormal medical history, concurrent medical condition, acute or chronic illness, or history of chronic illness (such as diabetes mellitus or other abnormalities of glucose homeostasis) sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous
Past surgery (e.g. stomach bypass) or medical condition that might affect absorption of the study drug when taken orally
Presence of abnormal physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the subject
Loss of more than 400 mL of blood within the 3 months before admission
Clinically relevant history of vital organ disease, or other organ or central nervous system disease (e.g. diabetes mellitus, liver disease, seizures, etc.)
Current or previous medical or psychiatric disorder that, in the opinion of the Investigator or the Sponsor, would increase the risk and ability to participate in and/or complete the study
Positive test for hepatitis B, hepatitis C or HIV
Febrile illness (e.g. fever) within 1 week before the first dose of study medication
History of a severe allergy, non-allergic drug reaction, severe adverse reaction to any drug, or multiple drug allergies
Hypersensitivity to any ingredient of the study medication, including the active ingredient (emodepside)
Presence or history of drug or alcohol abuse in the last year, or intake of more than 21 units (1 unit = 1/2 pint of beer, 1 small glass of wine or 1 measure of spirits) of alcohol weekly
Regular daily consumption of more than one litre of beverages containing xanthine
Daily consumption of more than 10 cigarettes or more than 6 grams (1/4 ounce) of tobacco
Use of a prescription medicine during the 28 days before the dose of study medication, or use of an over-the-counter medicine (with exception of acetaminophen (paracetamol)), during the 7 days before the dose of study medication
Use, within 14 days before the dose of study medication, of dietary supplements or herbal remedies (such as St John's Wort) that are known to be inducers or inhibitors of CYP3A4, or other co-medications known to be relevant substrates of CYP3A4 (see list in the Study Procedures Manual)
Use, within 14 days before the dose of study medication, of dietary supplements or herbal remedies that are known to be strong inhibitors of P-gp, or other co-medications known to be relevant substrates of P-gp (see list in the Study Procedures Manual)

Relevant pathological abnormalities in the ECG at screening, such as:

second or third-degree atrioventricular (AV) block prolongation of the QRS complex > 120 msec, QTc-interval (QTcB or QTcF) > 450 msec. The mean of the triplicate ECG readings will be used to assess eligibility.

Evidence of drug abuse (via urine testing) at the screening assessment or admission to the ward
Use of excluded therapies that may impact on the interpretation of study results in the opinion of the Investigator or Sponsor
Objection by General Practitioner (GP) to subject entering trial
History of residing for 6 or more continuous months during the last 3 years in regions with endemic parasitic infections, as determined by the Investigator
Possibility that subject will not cooperate with the requirements of the protocol