Drug Drug Interaction of BI 201335 and Tenofovir

NCT01340196 | Completed Phase 1 Results

• 1 other identifier: 1220.50
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (6)

• Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15

  Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.

  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

• Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15

  Maximum measured concentration of analyte in plasma (Cmax), at steady state.

  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

• Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15

  Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.

  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

• Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22

  Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.

  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

• Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22

  Maximum measured concentration of analyte in plasma (Cmax), at steady state.

  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

• Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22

  Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.

  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

Secondary Outcomes (2)

• Number of Patients With Drug Related Adverse Events During the Trial

  From drug administration up to 32 days.

• Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG

  From drug administration up to 32 days.

Study Arms (1)

sequence 1

EXPERIMENTAL

tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through day 22 (morning dose on day 22 only)

Drug: tenofovir/BI 201335

Interventions

tenofovir/BI 201335 DRUG

tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22

sequence 1

Eligibility Criteria

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

You may qualify if:

• Healthy males and female subjects and according to medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram and clinical laboratory tests; all with acceptable findings.
• Age =18 to =55 years
• Weighing at least 50 kg, and body mass index \>=18.5 and BMI \<=29.9 kg/m2 (Body Mass Index).
• Volunteers must not leave the research unit, during the entire length of the study and must be willing to comply with the protocol and complete all study-related activities.

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance, as assessed by the investigator.
• Active diseases of the gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological system, clinically relevant electrolyte disorders or bleeding disorders that require current medical treatment.
• Diseases of the central nervous system or psychiatric disorders.
• History of photosensitivity or recurrent rash.
• History of orthostatic hypotension, fainting spells or blackouts.
• Chronic or clinically relevant acute infections.
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant.
• Intake of drugs with a long half-life \>24:00 hours within at least one month or less than ten half lives of the respective drug before enrollment in the study (with the exception of hormonal contraceptives).
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment as nutraceuticals and herbal remedies that would interfere with either the absorption, distribution or metabolism of BI 201335 NA, or that prolong the QT/QTc interval.
• Use of any investigational drug within 30 days prior to enrollment; or the planned use of any investigational drug during the course of the current study.
• Smoking (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to abstain from smoking more than 3 cigarettes/day during the period of dosing with study medication.
• Drug and alcohol abuse (\>60g/day).
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
• Excessive physical activities within one week prior to administration or during the trial.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1220.50.0001 Boehringer Ingelheim Investigational Site

Buffalo, New York, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Last Updated: July 31, 2015
• Results First Posted: July 31, 2015

Record last verified: 2015-07

Locations

US (1)