Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers

Inclusion criteria

• Males or females who met the inclusion/exclusion criteria, females who are not pregnant nor nursing, and who agreed to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
• Healthy HIV negative adult volunteers
• Age ≥18 and ≤60 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2
• Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

Exclusion criteria

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (>24 hours) within at least one month prior to study drug administration and during the trial
• Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Current smoker
• Alcohol abuse (more than 60 g/day)
• Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
• Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
• Excessive physical activities (within one week prior to study drug administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator
• Inability to comply with dietary regimen required by the protocol
• Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
• Pregnant or lactating females