Thorough QT/QTc of Pritelivir in Healthy Subjects

Inclusion Criteria

• Subject had been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which they may be exposed and had given written consent to participation in the trial prior to trial start and any trial-related procedure.
• Healthy male and female subjects of any ethnic origin, aged between 18 and 45 years (inclusive). Assessed as healthy based on a Screening examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results.
• Male subjects were not planning to father or to donate sperms for in vitro fertilization during the trial and for at least 3 months after dosing of trial medication. Adequate contraception (see below) had to be used during sexual intercourse with women of childbearing potential to make sure the fathering of a child was ruled out during the trial and during the 3 months after dosing of trial medication.

Women of childbearing potential had to perform adequate contraception. They should also not have donated ova during the trial and for at least 3 months after dosing of trial medication.

Adequate contraception was defined as a combination of a highly effective method of birth control and additional barrier contraception. Highly effective method of birth control was defined as follows: combined (estrogen and progesterone) oral contraceptives, combined hormonal vaginal rings, hormone implants, hormone injectables, or intrauterine device that needed to be in place for a period of at least 2 months prior to Screening and continue for at least 3 months after dosing of trial medication. Additional barrier contraception (the following methods were allowed: condom of the male, diaphragm with spermicide, cervical cap with spermicide) had to be used for the duration of the trial, defined as from the time of Screening to the End of Trial examination, and for at least 3 months after dosing of trial medication. A single barrier method alone or abstinence alone was not acceptable. Homosexual female subjects who refrained from heterosexual intercourse for at least 3 months prior to Screening could be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the End of Trial examination, and for at least 3 months after dosing of trial medication.

Women of non-childbearing potential could be included if surgically sterile (documented complete hysterectomy, supracervical hysterectomy or bi-tubal ligations; partial hysterectomy was not sufficient) or if postmenopausal (who have a history of no menses of at least 24 months at screening and postmenopausal status was confirmed by follicle stimulating hormone [FSH] test at screening).

• In women, negative serum β-HCG (beta-human chorionic gonadotropin) test at Screening and negative urine β-HCG test on Day -2.
• Subject agreed to pharmacogenomic blood sampling.
• Subject had to be willing and able to swallow up to 4 tablets (pritelivir or matching placebo) and 1 capsule (over-encapsulated moxifloxacin or matching placebo) at least twice during the trial.
• Normal body weight as evidenced by a Body Mass Index (BMI) ≥18.0 and ≤25.0 kg/m2, and a body weight ≥50.0 kg at Screening.
• Subjects must have a negative test result for HIV-I- and -II-antibody, HBsAg, anti-hepatitis B core antigen (HBc) (IgG + IgM) and anti-hepatitis C virus (HCV) at Screening.
• Subjects had to have negative urine tests for drugs of abuse (benzodiazepines, opiates, amphetamines, methadone, cocaine, cannabinoids, barbiturates, cotinine) and negative breath alcohol tests at Screening and Admission for the in-house phase (Day -2).
• Normal triplicate 12-lead ECG measured after 10 minutes in the supine position at screening and on admission on Day -2 showing regular sinus rhythm with a well-defined end of T.
• Normal 24-hour 12-lead ECG at screening.

Exclusi