Trial Outcomes & Findings for Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine (NCT NCT01402947)
NCT ID: NCT01402947
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 |
MMX Placebo + Ciprofloxacin First
MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
|
MMX Mesalazine/Mesalamine + Ciprofloxacin First
MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
|
|---|---|---|
|
First Intervention
STARTED
|
15
|
15
|
|
First Intervention
COMPLETED
|
15
|
14
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
15
|
14
|
|
Second Intervention
COMPLETED
|
15
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
MMX Placebo + Ciprofloxacin First
MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
|
MMX Mesalazine/Mesalamine + Ciprofloxacin First
MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
Baseline Characteristics
Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
Baseline characteristics by cohort
| Measure |
MMX Placebo + Ciprofloxacin First
n=15 Participants
MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
|
MMX Mesalazine/Mesalamine + Ciprofloxacin First
n=15 Participants
MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 11.73 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 10.95 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
|
Age, Customized
18 to 55 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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. Safety Analysis Set defined as 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 |
MMX Placebo + Ciprofloxacin
n=29 Participants
MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
|
MMX Mesalazine/Mesalamine + Ciprofloxacin
n=30 Participants
MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR
|
7805 ng*h/ml
Standard Deviation 1949
|
7934 ng*h/ml
Standard Deviation 2101
|
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. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.
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 |
MMX Placebo + Ciprofloxacin
n=29 Participants
MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
|
MMX Mesalazine/Mesalamine + Ciprofloxacin
n=30 Participants
MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR
|
1455 ng/ml
Standard Deviation 518
|
1433 ng/ml
Standard Deviation 446
|
Adverse Events
MMX Placebo + Ciprofloxacin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MMX Mesalazine/Mesalamine + Ciprofloxacin
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 |
MMX Placebo + Ciprofloxacin
n=29 participants at risk
MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
|
MMX Mesalazine/Mesalamine + Ciprofloxacin
n=30 participants at risk
MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophogeal reflex disease
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
Presyncope
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
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