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Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02080780
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Ventrus Biosciences, Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]
Interventions Drug: Clarithromycin XL
Drug: 2% Diltiazem
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2% Diltiazem & Clarithromycin XL
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3 parts:

  1. - Diltiazem Single Dose
  2. - Clarithromycin XL (Days 4-9)
  3. - Diltiazem Single Dose after Clarithromycin

Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg

2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title 2% Diltiazem & Clarithromycin XL
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3 parts:

  1. - Diltiazem Single Dose
  2. - Clarithromycin XL (Days 4-9)
  3. - Diltiazem Single Dose after Clarithromycin

Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg

2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
32.9  (10.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
7
  29.2%
Male
17
  70.8%
1.Primary Outcome
Title Peak Plasma Concentration (Cmax) of 2% Diltiazem
Time Frame 9 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diltiazem Single Dose Diltiazem Single Dose After Clarithromycin
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On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng / mL
0.340  (0.299) 0.624  (0.475)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diltiazem Single Dose Clarithromycin XL (Days 4-9) Diltiazem Single Dose After Clarithromycin
Hide Arm/Group Description On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg) On Days 4 through 9, subjects received once daily doses of clarithromycin XL (2 tablets, 500 mg/tablet, total dose = 1000 mg/day; 6000 mg total in 6 days) with 24 hours between doses. 2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
All-Cause Mortality
Diltiazem Single Dose Clarithromycin XL (Days 4-9) Diltiazem Single Dose After Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diltiazem Single Dose Clarithromycin XL (Days 4-9) Diltiazem Single Dose After Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diltiazem Single Dose Clarithromycin XL (Days 4-9) Diltiazem Single Dose After Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/24 (16.67%)   3/24 (12.50%)   8/24 (33.33%) 
Gastrointestinal disorders       
Diarrhea   3/24 (12.50%)  1/24 (4.17%)  0/24 (0.00%) 
Nausea   0/24 (0.00%)  2/24 (8.33%)  0/24 (0.00%) 
Investigations       
Alanine aminotransferase increased   0/24 (0.00%)  0/24 (0.00%)  7/24 (29.17%) 
Aspartate aminotransferase increased   0/24 (0.00%)  0/24 (0.00%)  4/24 (16.67%) 
Nervous system disorders       
Headache   2/24 (8.33%)  1/24 (4.17%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Ventrus
Organization: Ventrus Biosciences
Phone: 646-706-5208
Responsible Party: Ventrus Biosciences, Inc
ClinicalTrials.gov Identifier: NCT02080780     History of Changes
Other Study ID Numbers: VEN307-DDI-001
First Submitted: March 4, 2014
First Posted: March 6, 2014
Results First Submitted: March 7, 2014
Results First Posted: April 14, 2014
Last Update Posted: April 14, 2014