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Trial record 85 of 388 for:    CLARITHROMYCIN

Influence of OATP1B1 and CYP2C9 Genotypes on the Pharmacokinetics of Bosentan Before and During Clarithromycin

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ClinicalTrials.gov Identifier: NCT01425229
Recruitment Status : Completed
First Posted : August 29, 2011
Results First Posted : August 4, 2015
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Gerd Mikus, Heidelberg University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Drug Interactions
Intervention Drug: Bosentan
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bosentan
Hide Arm/Group Description Bosentan pharmacokinetics
Period Title: Bosentan Single Dose
Started 16
Completed 16
Not Completed 0
Period Title: Bosentan Steady-state
Started 16
Completed 16
Not Completed 0
Period Title: Bosentan During Clarithromycin
Started 16
Completed 16
Not Completed 0
Arm/Group Title Bosentan
Hide Arm/Group Description Bosentan PK
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
31.6  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
6
  37.5%
Male
10
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 16 participants
16
1.Primary Outcome
Title AUC
Hide Description AUC of bosentan after first-dose, at steady-state and during clarithromycin therapy
Time Frame 0-infinity; dosing interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bosentan After First Dose Bosentan at Steady-state Bosentan During Clarithromycin
Hide Arm/Group Description:
administration of bosentan 125 mg p.o. single dose
administration of bosentan 125 mg p.o. b.i.d. on day 2-10
administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
Overall Number of Participants Analyzed 16 16 16
Geometric Mean (95% Confidence Interval)
Unit of Measure: h*ng/ml
11900
(9730 to 14500)
6830
(5330 to 8750)
25500
(21700 to 29900)
2.Primary Outcome
Title Cmax
Hide Description Cmax after the first dose of bosentan, at steady-state, during clarithromycin
Time Frame after first dose, at steady-state, during clarithromycin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bosentan After First Dose Bosentan at Steady-state Bosentan During Clarithromycin
Hide Arm/Group Description:
administration of bosentan 125 mg p.o. single dose
administration of bosentan 125 mg p.o. b.i.d. on day 2-10
administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
Overall Number of Participants Analyzed 16 16 16
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/ml
1890
(1540 to 2310)
1460
(1120 to 1900)
5570
(4600 to 6740)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bosentan After First Dose Bosentan at Steady-state Bosentan During Clarithromycin
Hide Arm/Group Description Bosentan PK after first dose Bosentan PK at steady-state Bosentan PK during clarithromycin
All-Cause Mortality
Bosentan After First Dose Bosentan at Steady-state Bosentan During Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bosentan After First Dose Bosentan at Steady-state Bosentan During Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bosentan After First Dose Bosentan at Steady-state Bosentan During Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/16 (56.25%)   9/16 (56.25%)   9/16 (56.25%) 
Gastrointestinal disorders       
Xerostomia   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Loss of apetite   1/16 (6.25%)  1/16 (6.25%)  0/16 (0.00%) 
Nausea   1/16 (6.25%)  1/16 (6.25%)  0/16 (0.00%) 
Flatulence   1/16 (6.25%)  1/16 (6.25%)  0/16 (0.00%) 
Epigastric pain   1/16 (6.25%)  1/16 (6.25%)  1/16 (6.25%) 
Diarrhoea   1/16 (6.25%)  1/16 (6.25%)  2/16 (12.50%) 
abdominal pain   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
General disorders       
Nasopharyngitis   3/16 (18.75%)  3/16 (18.75%)  2/16 (12.50%) 
Nasal congestion   4/16 (25.00%)  4/16 (25.00%)  1/16 (6.25%) 
Headache   5/16 (31.25%)  4/16 (25.00%)  5/16 (31.25%) 
Night sweats   1/16 (6.25%)  1/16 (6.25%)  0/16 (0.00%) 
Dizziness   1/16 (6.25%)  1/16 (6.25%)  2/16 (12.50%) 
Fatigue   1/16 (6.25%)  1/16 (6.25%)  1/16 (6.25%) 
taste disorder   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
concentration difficulty   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
tinnitus   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Investigations       
increase of creatinine kinase   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Increase of aspartate transaminase   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Tachykardia   0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders       
Eczema   1/16 (6.25%)  1/16 (6.25%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Gerd Mikus
Organization: University of Heidelberg
Phone: 4962215639197
EMail: gerd.mikus@med.uni-heidelberg.de
Layout table for additonal information
Responsible Party: Gerd Mikus, Heidelberg University
ClinicalTrials.gov Identifier: NCT01425229     History of Changes
Other Study ID Numbers: K318
2010-021392-93 ( EudraCT Number )
First Submitted: August 26, 2011
First Posted: August 29, 2011
Results First Submitted: July 8, 2014
Results First Posted: August 4, 2015
Last Update Posted: May 31, 2017