Electrophysiological Effects of Tipranavir Co-administered With Ritonavir on the QT Interval in Healthy Female and Male Subjects

NCT02248883 | Completed Phase 1

• 1 other identifier: 1182.60
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the QT interval more than placebo co-administered with ritonavir

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in individually heart rate corrected QT interval length (QTcI)

  baseline and 2 to 4 hours after drug administration on day3

Secondary Outcomes (2)

• Change from baseline in (QTcI)

  baseline and 2 to 4 hours after drug administration on day 1

• Change from baseline in (QTcI)

  baseline and 1 to 12 hours after drug administration on day1 and 3

Study Arms (3)

low TPV/RTV

EXPERIMENTAL

Drug: TPV low; Drug: Moxifloxacin; Drug: RTV

high TPV/RTV

EXPERIMENTAL

Drug: Moxifloxacin; Drug: TPV high; Drug: RTV

Placebo/RTV

EXPERIMENTAL

Drug: Placebo; Drug: Moxifloxacin; Drug: RTV

Interventions

TPV low DRUG

low TPV/RTV

Placebo DRUG

Placebo/RTV

Moxifloxacin DRUG

Also known as: Avelox®

Placebo/RTV; high TPV/RTV; low TPV/RTV

TPV high DRUG

high TPV/RTV

RTV DRUG

Placebo/RTV; high TPV/RTV; low TPV/RTV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female and male volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
• Age ≥ 18 and Age ≤ 55 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Gastrointestinal tract surgery (except appendectomy)
• Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Relevant acute, chronic or active chronic infections (e.g. hepatitis, HIV).
• History of allergy/hypersensitivity (including drug allergies) that are 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 or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 25, 2014
• Study Start: December 1, 2005
• Primary Completion: March 1, 2006
• Last Updated: September 25, 2014

Record last verified: 2014-09