Drug Drug Interaction of BI 201335 and Tenofovir

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01340196

First received: April 20, 2011

Last updated: July 3, 2015

Last verified: July 2015

History of Changes

Results First Received: July 3, 2015

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Intervention:	Drug: tenofovir/BI 201335

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
All Participants	tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)

Participant Flow for 3 periods

Period 1: Treat. Period 1 (Tenofovir)

	All Participants
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Period 2: Treat. Period 2 (Tenofovir/Faldaprevir)

	All Participants
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Period 3: Treat. Period 3 (Faldaprevir)

	All Participants
STARTED	16
COMPLETED	14
NOT COMPLETED	2
Adverse Event	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
All Participants	tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)

Baseline Measures

	All Participants
Number of Participants [units: participants]	16
Age [units: years] Mean (Standard Deviation)	37 (8.6)
Gender [units: participants]
Female	3
Male	13

Outcome Measures

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1. Primary:

Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15 [ Time Frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 ]

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2. Primary:

Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15 [ Time Frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15 ]

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3. Primary:

Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15 [ Time Frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 ]

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4. Primary:

Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22 [ Time Frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22 ]

Show Outcome Measure 4

5. Primary:

Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22 [ Time Frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22 ]

Show Outcome Measure 5

6. Primary:

Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22 [ Time Frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22 ]

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7. Secondary:

Number of Patients With Drug Related Adverse Events During the Trial [ Time Frame: From drug administration up to 32 days. ]

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8. Secondary:

Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG [ Time Frame: From drug administration up to 32 days. ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01340196 History of Changes
Other Study ID Numbers:	1220.50
Study First Received:	April 20, 2011
Results First Received:	July 3, 2015
Last Updated:	July 3, 2015
Health Authority:	United States: Food and Drug Administration

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