Trial Outcomes & Findings for Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects (NCT NCT02080780)
NCT ID: NCT02080780
Last Updated: 2014-04-14
Results Overview
To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
9 days
Results posted on
2014-04-14
Participant Flow
Participant milestones
| Measure |
2% Diltiazem & Clarithromycin XL
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 Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
Baseline characteristics by cohort
| Measure |
2% Diltiazem & Clarithromycin XL
n=24 Participants
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)
|
|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 daysTo evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
Outcome measures
| Measure |
Diltiazem Single Dose
n=24 Participants
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)
|
Diltiazem Single Dose After Clarithromycin
n=24 Participants
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
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) of 2% Diltiazem
|
0.340 ng / mL
Standard Deviation 0.299
|
0.624 ng / mL
Standard Deviation 0.475
|
Adverse Events
Diltiazem Single Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Clarithromycin XL (Days 4-9)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Diltiazem Single Dose After Clarithromycin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diltiazem Single Dose
n=24 participants at risk
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)
|
Clarithromycin XL (Days 4-9)
n=24 participants at risk
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.
|
Diltiazem Single Dose After Clarithromycin
n=24 participants at risk
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
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/24
|
0.00%
0/24
|
29.2%
7/24
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/24
|
0.00%
0/24
|
16.7%
4/24
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
3/24
|
4.2%
1/24
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
8.3%
2/24
|
4.2%
1/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24
|
8.3%
2/24
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60