NCT02251132 is a Phase 1 clinical trial of TPV low 1 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02251132?

NCT02251132 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02251132?

Interventions in NCT02251132: TPV low 1, TPV low 2, TPV medium, TPV high 1, TPV high 2, RTV low, Ritonavir high, Radiolabelled erythromycin.

Is NCT02251132 still recruiting?

NCT02251132 is currently completed. Last updated 25 September 2014.

Last reviewed 2014-09-25 · How we verify

NCT02251132

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-label, Parallel Group, Multiple-dose Investigation of the Pharmacokinetics of Tipranavir Soft Elastic Capsules SEDDS and Ritonavir Soft Gel Capsules and Their Effects on Cytochrome P-450 (3A4) Activity in Normal Healthy Volunteers

Completed Phase 1 Last updated 25 September 2014

What this trial tests

Phase 1 trial testing TPV low 1 in Healthy in 113 participants. Completed.

Timeline

1 October 2000

Primary endpoint
1 December 2000

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	113
Start date	1 October 2000
Primary completion	1 December 2000

Drugs / interventions tested

TPV low 1 — full drug profile →
TPV low 2
TPV medium — full drug profile →
TPV high 1 — full drug profile →
TPV high 2 — full drug profile →
RTV low
Ritonavir high
Radiolabelled erythromycin — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Trough plasma concentration at steady state (Cmin,ss)
Time frame: up to 24 hours
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: up to 24 hours
Time of maximum concentration (tmax)
Time frame: up to 24 hours
Area under the plasma concentration time curve from 0 to 12 hours (AUC0-12)
Time frame: up to 12 hours

Sponsor's own description

The objective of this study is to establish the tipranavir-ritonavir steady-state dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally, the short-term safety and tolerance of this drug combination will be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02251132 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 25 September 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02251132.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing