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Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Darunavir

Ritonavir

BI 201335

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age 18 to 55 years (incl.)
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
History of photosensitivity or recurrent rash.
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug 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)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 30 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
ALT outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Positive serology tests for Human immunodeficiency virus (HIV) and hepatitis B / C virus
Vulnerable subjects (e.g. persons kept in detention)

Sites / Locations

1220.49.1 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

BI 201335

Darunavir 400 mg

Ritonavir 100 mg

Arm Description

capsule for oral administration

tablet for oral administration

Outcomes

Primary Outcome Measures

AUCτ,ss of Darunavir

area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities

Cτ,ss of Darunavir

concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir

Cmax,ss of Darunavir

maximum measured concentration of the analyte in plasma at steady-state

Secondary Outcome Measures

Tmax,ss of Darunavir

time from last dosing to maximum concentration of the analyte in plasma at steady state

Full Information

NCT ID

NCT01374802

First Posted

June 8, 2011

Last Updated

July 3, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01374802

Brief Title

Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

Official Title

Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI 201335

Arm Type

Experimental

Arm Description

capsule for oral administration

Arm Title

Darunavir 400 mg

Arm Type

Experimental

Arm Description

tablet for oral administration

Arm Title

Ritonavir 100 mg

Arm Type

Experimental

Arm Description

tablet for oral administration

Intervention Type

Drug

Intervention Name(s)

Darunavir

Intervention Description

400 mg tablet for oral administration

Intervention Type

Drug

Intervention Name(s)

Ritonavir

Intervention Description

tablet for oral administration

Intervention Type

Drug

Intervention Name(s)

BI 201335

Primary Outcome Measure Information:

Title

AUCτ,ss of Darunavir

Description

Time Frame

0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)

Title

Cτ,ss of Darunavir

Description

concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir

Time Frame

0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)

Title

Cmax,ss of Darunavir

Description

maximum measured concentration of the analyte in plasma at steady-state

Time Frame

0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)

Secondary Outcome Measure Information:

Title

Tmax,ss of Darunavir

Description

time from last dosing to maximum concentration of the analyte in plasma at steady state

Time Frame

0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests Age 18 to 55 years (incl.) Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation. Exclusion criteria: Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance Any evidence of a clinically relevant concomitant disease Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders History of photosensitivity or recurrent rash. Surgery of the gastrointestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of relevant orthostatic hypotension, fainting spells or blackouts. Chronic or relevant acute infections History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug 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) Inability to refrain from smoking on trial days Alcohol abuse (more than 30 g/day) Drug abuse Blood donation (more than 100 mL within four weeks prior to administration or during the trial) ALT outside the normal range or any other laboratory value outside the reference range that is of clinical relevance Inability to comply with dietary regimen of trial site The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions Positive serology tests for Human immunodeficiency virus (HIV) and hepatitis B / C virus Vulnerable subjects (e.g. persons kept in detention)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1220.49.1 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/

Description

Related Info

Learn more about this trial

Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

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