Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT01371006
  4. Details
NCT01371006 Clinical Trial

Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers

Healthy Clinical Trial

Official title:
Effect of Multiple Dosing With 240mg q 12hrs BI 201335 on the Pharmacokinetics of 50 mg Single Dose Efavirenz and Effect of Multiple Dosing With 600mg QD Efavirenz on Cyp 3A4 and the Pharmacokinetics of BI 201335 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01371006
Other study ID # 1220.20
Secondary ID
Status Completed
Phase Phase 1
First received June 9, 2011
Last updated July 3, 2015
Start date June 2011

Study information
Verified date July 2015
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.

To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion criteria:

Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9

Exclusion criteria:

1. Any finding on medical examination and ECG (Electrocardiography) deviating from normal

2. Active diseases

3. History of photosensitivity or rash

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• low dose
efavirenz single dosing once daily
• normal dose
efavirenz once daily
• low dose
Efavirenz single dosing once daily

Locations
Country Name City State
Switzerland 1220.20.41001 Boehringer Ingelheim Investigational Site Basel

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Group A - Efavirenz: Cmax Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz No
Primary Group A - Efavirenz: AUC0-8 Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz No
Primary Group B - Faldaprevir: Cmax,ss Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir No
Primary Group B - Faldaprevir: AUC0-12h,ss Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir No
Primary Group B - Faldaprevir: C12,ss Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir No
Secondary Group A - Faldaprevir: Cmax,ss Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir No
Secondary Group A - Faldaprevir: Tmax,ss Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir No
Secondary Group A - Faldaprevir: AUC0-12h,ss Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir No
Secondary Group A - Faldaprevir: C12,ss Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir No
Secondary Group A - Efavirenz: Tmax Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz No
Secondary Group B - Faldaprevir: Tmax,ss Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir No
Secondary Group B - Midazolam: Cmax Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam No
Secondary Group B - Midazolam: Tmax Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam No
Secondary Group B - Midazolam: AUC0-8 Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam No
Secondary Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. From first treatment administration (Day 1) up to Day 24 No
Secondary Group A - Number of Participants With Drug Related Adverse Events Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.		 From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24) No
Secondary Group B - Number of Participants With Drug Related Adverse Events Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.		 From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24) No
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1

External Links