Pharmacokinetics of Tipranavir/Ritonavir and Its Metabolites in Healthy Male Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tipranavir; Drug: Ritonavir; Drug: 14C-Tipranavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02253797

1182.24

Details and patient eligibility

About

Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion and mass balance of parent compound and radioactivity at steady-state; to isolate, identify and quantify major metabolites of tipranavir in plasma, urine and feces

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy HIV-negative male subjects as determined by results of screening. Healthiness was determined by medical history, laboratory testing and 12-lead ECG
2. Signed written informed consent in accordance with Good Clinical Practice (GCP)
3. Age >18 and <=60 years
4. Subjects within 20% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables
5. Ability to swallow numerous large capsules
6. Willingness to abstain from smoking, ingesting methylxanthine containing drinks or food (coffee, tea, cola, chocolate, etc.), or ingesting alcohol, St. John's Wort, milk thistle, garlic supplements, Seville oranges, and grapefruit or grapefruit juice for the duration of the study

Exclusion criteria

1. Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
2. History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
3. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator and/or the sponsor
4. Subjects with a history of drug abuse or alcoholism
5. Chronic or relevant acute (within 2 weeks of screening) infections
6. Subjects who have taken prescription medications, over-the-counter drugs, or herbal preparations within 2 weeks of the start of the trial
7. Participation in another trial with an investigational drug (in the 30 days prior to screening)
8. Blood donation >400 mL (within 1 month prior to treatment administration or during the trial)
9. Any laboratory value that represents a Division of DAIDS (DAIDS) toxicity Grade >1
10. Positive urine drug screen, positive HIV antibody, positive Hepatitis C Ribonucleic acid (RNA), or positive Hepatitis B surface antigen
11. History of any familial bleeding disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

TPV/r followed by 14C-radiolabeled TPV

Experimental group

Description:

Tipranavir/Ritonavir dosed to steady state followed by single-dose 14C-radiolabeled tipranavir co-administered with Tipranavir/Ritonavir

Treatment:

Drug: 14C-Tipranavir

Drug: Ritonavir

Drug: Tipranavir