Trial Outcomes & Findings for Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine (NCT NCT01418365)
NCT ID: NCT01418365
Last Updated: 2021-06-09
Results Overview
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Assessed over a 24-hour period starting post-dose on day 4
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Metronidazole + MMX Placebo First
Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
|
Metronidazole + MMX Mesalazine/Mesalamine First
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
|
|---|---|---|
|
First Intervention
STARTED
|
15
|
15
|
|
First Intervention
COMPLETED
|
14
|
14
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
14
|
14
|
|
Second Intervention
COMPLETED
|
14
|
13
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Metronidazole + MMX Placebo First
Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
|
Metronidazole + MMX Mesalazine/Mesalamine First
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
1
|
|
First Intervention
Non-compliance
|
1
|
0
|
|
Second Intervention
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Baseline characteristics by cohort
| Measure |
Metronidazole + MMX Placebo First
n=15 Participants
Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
|
Metronidazole + MMX Mesalazine/Mesalamine First
n=15 Participants
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Age, Customized
Between 18 and 55 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed over a 24-hour period starting post-dose on day 4Population: Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consists of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Outcome measures
| Measure |
Metronidazole + MMX Placebo
n=29 Participants
Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
|
Metronidazole + MMX Mesalazine/Mesalamine
n=29 Participants
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
|
|---|---|---|
|
Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole
|
217686 ng*h/ml
Standard Deviation 49693
|
215809 ng*h/ml
Standard Deviation 48681
|
PRIMARY outcome
Timeframe: Assessed over a 24-hour period starting post-dose on day 4Population: Pharmacokinetic Analysis Set
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Outcome measures
| Measure |
Metronidazole + MMX Placebo
n=29 Participants
Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
|
Metronidazole + MMX Mesalazine/Mesalamine
n=29 Participants
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole
|
28193 ng/ml
Standard Deviation 6249
|
28057 ng/ml
Standard Deviation 5522
|
Adverse Events
Metronidazole + MMX Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Metronidazole + MMX Mesalazine/Mesalamine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metronidazole + MMX Placebo
n=29 participants at risk
Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
|
Metronidazole + MMX Mesalazine/Mesalamine
n=29 participants at risk
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
6.9%
2/29 • Number of events 2
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
10.3%
3/29 • Number of events 3
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Number of events 2
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
6.9%
2/29 • Number of events 3
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/29
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Number of events 5
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
10.3%
3/29 • Number of events 3
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
0.00%
0/29
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/29
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
0.00%
0/29
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
|
Vascular disorders
Hot flush
|
3.4%
1/29 • Number of events 1
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
0.00%
0/29
Safety Analysis Set consists of subjects who take at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER