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.
• ✓. 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.

Exclusion criteria