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

NCT02251873 | Completed Phase 1

• 1 other identifier: 1182.42
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• (AUC 0-12) Area under the plasma concentration time curve from 0-12 hours

  up to 12 hours after dose administration

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 12 hours after dose administration

• (C6h) drug concentration in plasma at 6 hours after drug administration

  up to 6 hours after dose administration

• (C12h) drug concentration in plasma at 12 hours after drug administration

  up to 12 hours after dose administration

• Cnh (plasma concentration n hours after drug administration)

  up to 12 hours after dose administration

Secondary Outcomes (8)

• Cmax,ss (maximum plasma concentration at steady state)

  up to 12 hours after dose administration

• MRT (mean residence time)

  up to 12 hours after dose administration

• Tmax (time to the maximum plasma concentration)

  up to 12 hours after dose administration

• CL/F (apparent oral clearance)

  up to 12 hours after dose administration

• Vz/F (apparent volume of distribution)

  up to 12 hours after dose administration

Study Arms (2)

TPV + RTV (low dose)+ ddI

EXPERIMENTAL

Drug: TPV + RTV (low dose); Drug: ddl

TPV+ RTV (high dose)+ ddI

EXPERIMENTAL

Drug: TPV + RTV (high dose); Drug: ddl

Interventions

TPV + RTV (low dose) DRUG

TPV + RTV (low dose)+ ddI

TPV + RTV (high dose) DRUG

TPV+ RTV (high dose)+ ddI

ddl DRUG

TPV + RTV (low dose)+ ddI; TPV+ RTV (high dose)+ ddI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: September 1, 2001
• Primary Completion: March 1, 2002
• Last Updated: September 29, 2014

Record last verified: 2014-09