Status:
COMPLETED
Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02253927
Start Date
May 1 2006
Last Update
October 1 2014
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