Study to Determine the Effects of Multiple-dose Omeprazole on the Single-dose Pharmacokinetics of Tipranavir (TPV) Coadministered With Ritonavir (RTV) in Healthy Adult Volunteers

NCT02253875 | Completed Phase 1

• 1 other identifier: 1182.84
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the effects of multiple-dose omeprazole on the single-dose pharmacokinetics of tipranavir and ritonavir

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax (Maximum plasma concentration of Tipranavir in plasma)

  up to 72 hours after drug administration

• AUC0-72h (Area Under Plasma Concentration-time curve of Tipranavir from 0-72 hr)

  up to 72 hours after drug administration

Secondary Outcomes (9)

• Cmax (Maximum plasma concentration of Ritonavir in plasma)

  up to 72 hours after drug administration

• AUC0-72h (Area Under Plasma Concentration-time curve of Ritonavir from 0-72 hr)

  up to 72 hours after drug administration

• AUC0-∞ (Area Under Plasma Concentration-time curve from 0 to infinity)

  up to 72 hours after drug administration

• MRT (Mean residence time)

  up to 72 hours after drug administration

• t1/2 (apparent terminal halflife)

  up to 72 hours after drug administration

Study Arms (1)

TPV + RTV + Omeprazole

EXPERIMENTAL

Drug: Tipranavir (TPV); Drug: Ritonavir; Drug: Omeprazole

Interventions

Tipranavir (TPV) DRUG

Also known as: (Aptivus ®)

TPV + RTV + Omeprazole

Ritonavir DRUG

Also known as: (Norvir-SEC®)

TPV + RTV + Omeprazole

Omeprazole DRUG

Also known as: (Antra®)

TPV + RTV + Omeprazole

Eligibility Criteria

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

You may qualify if:

• Male and female healthy volunteers between 18 and 60 years of age inclusive
• Clinically normal medical history
• Clinically normal findings on physical examination
• Clinically normal laboratory values
• Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive
• Ability to swallow large capsules without difficulty
• Capable of comprehending and communicating effectively with the investigator and site staff
• Signed and dated written informed consent form, in accordance with Ethics Committee and regulatory guidelines prior to trial participation
• Willingness to abstain from ingesting substances which may alter plasma drug levels by interactions with the cytochrome P450 system during the 14 days of the study
• Willingness to abstain from alcohol for 48 hours prior to Visit 2 and for the duration of the study
• Willingness to abstain from ingesting grapefruit and grapefruit juice for 7 days before Visit 2 and for the duration of the study
• Negative pregnancy test (β-hCG)
• Negative HIV serology
• Negative hepatitis serology

You may not qualify if:

• Any clinically significant disease (a significant disease is defined as a disease, which in the opinion of the investigator may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study or the subject's ability to participate in the study)
• Clinically significant abnormal baseline hematology, blood chemistry or urinalysis findings normal at Visit 2
• Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), cholesterol, triglyceride or glucose greater than the upper limit of normal at Visit 2
• Treatment with any investigational drug within 90 days prior to the first dose of study medication
• Inability to adhere to the requirements of the protocol as assessed by the investigator
• Prior TPV use
• Subjects who are taking or have taken medications metabolized through the Cytochrome P-450 (CYP450) enzyme system within 30 days prior to Visit 2
• Subject with a seated systolic blood pressure either \<100 mmHg or \>150 mmHg; resting heart rate either \<50 beats/min or \>100 beats/min
• Subject with a history of any illness or allergy that in the investigator opinion might confound the results of the study, or pose additional risk to the subject with the administering of TPV/r or omeprazole
• Subject who have had an acute illness within 14 days prior to Visit 2
• Subject who are currently taking or have taken over-the-counter medications in the 14 days prior to Visit 2, or subjects who are currently taking any prescription medication
• Known hypersensitivity to TPV, RTV, omeprazole or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
• Female subjects who are of reproductive potential and who are:
• Pregnant or breast-feeding
• Have a positive serum β-hCG (pregnancy test) at screening visit (Visit 1)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

tipranavir; Ritonavir; Omeprazole

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

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

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: November 1, 2005
• Primary Completion: February 1, 2006
• Last Updated: October 1, 2014

Record last verified: 2014-09