Evaluation of the Pharmacokinetic Interaction of Steady State Tipranavir and Ritonavir or Tipranavir and Ritonavir With Single Dose Didanosine in Healthy Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ddl

Drug: TPV + RTV (low dose)

Drug: TPV + RTV (high dose)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02251873

1182.42

Details and patient eligibility

About

Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the short-term safety of this combination

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female subjects as determined by results of screening
Female subjects were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol and no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) for at least one month prior to administration of study medication, during the study and at least one month after release from the study. Women were to have negative pregnancy tests
Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Age >=18 and <=60 years
Body mass index (BMI) >=18.5 and <=29.9 kg/m2

Exclusion criteria

Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B, Hepatitis C, or HIV infection
History of orthostatic hypotension, fainting spells and blackouts
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator including study drugs
Intake of drugs with a long half-life (> 24 hours) or enzyme altering drug within 1 month prior to administration of study drugs
Use of any drugs that might have influenced the results of the trial within 10 days prior to administration or during the trial (in addition to specific medication prohibitions mentioned in exclusion criteria above)
Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing products or tobacco within one week of study drug administration
Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
Alcohol abuse (> 60 g/day)
Drug abuse
Blood or plasma donation within 1 month prior to administration or during the trial
Excessive physical activities within 5 days prior to administration or during the trial
Following specific laboratory findings: activated partial thromboplastin time (aPTT), prothrombin time international normalised ratio (INR), aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl-transferase (GGT), amylase, lipase, or triglyceride above the normal range
Any other laboratory value outside the clinically accepted reference range and of clinical relevance
History of any familial bleeding disorder
Inability to swallow multiple large capsules
Inability to comply with dietary regimen of study centre
Inability to comply with investigator's instructions