Trial Outcomes & Findings for A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy (NCT NCT02419001)
NCT ID: NCT02419001
Last Updated: 2018-11-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
2 weeks
Results posted on
2018-11-27
Participant Flow
Participant milestones
| Measure |
Low Dose
1 g ceftriaxone and two low doses (75 mg) of SYN-004
|
High Dose
1 g ceftriaxone and two high doses (150 mg) of SYN-004
|
|---|---|---|
|
Period 1- Ceftriaxone Without SYN-004
STARTED
|
6
|
5
|
|
Period 1- Ceftriaxone Without SYN-004
COMPLETED
|
5
|
5
|
|
Period 1- Ceftriaxone Without SYN-004
NOT COMPLETED
|
1
|
0
|
|
Period 2- Ceftriaxone With SYN-004
STARTED
|
5
|
5
|
|
Period 2- Ceftriaxone With SYN-004
COMPLETED
|
5
|
5
|
|
Period 2- Ceftriaxone With SYN-004
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Low Dose
1 g ceftriaxone and two low doses (75 mg) of SYN-004
|
High Dose
1 g ceftriaxone and two high doses (150 mg) of SYN-004
|
|---|---|---|
|
Period 1- Ceftriaxone Without SYN-004
AE w/ ceftriaxone, not dosed w/ IP
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
Baseline characteristics by cohort
| Measure |
Low Dose
n=6 Participants
1 g ceftriaxone and two low doses of SYN-004
|
High Dose
n=5 Participants
1 g ceftriaxone and two high doses of SYN-004
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksOutcome measures
| Measure |
Treatment Sequence AB
n=5 Participants
Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
|
Treatment Sequence AC
n=5 Participants
Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
|
|---|---|---|
|
Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.
Period 1
|
137,800.0 ng/mL
Standard Deviation 10,709.8
|
178,600.0 ng/mL
Standard Deviation 34,623.7
|
|
Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.
Period 2
|
143,800.0 ng/mL
Standard Deviation 13,103.4
|
169,200.0 ng/mL
Standard Deviation 32,782.6
|
PRIMARY outcome
Timeframe: 2 weeksSamples were collected at 0.25 h, 0.5 through 2 h, and 3 through 7 h after the infusion start. Standard deviations may be 0 if all collected T max values occur at the same time.
Outcome measures
| Measure |
Treatment Sequence AB
n=5 Participants
Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
|
Treatment Sequence AC
n=5 Participants
Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
|
|---|---|---|
|
Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.
Period 1
|
0.5 hours
Standard Deviation 0.0
|
0.5 hours
Standard Deviation 0.0
|
|
Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.
Period 2
|
0.5 hours
Standard Deviation 0.0
|
0.5 hours
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: 2 weeksOutcome measures
| Measure |
Treatment Sequence AB
n=5 Participants
Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
|
Treatment Sequence AC
n=5 Participants
Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
|
|---|---|---|
|
Ceftriaxone PK Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) With (Period 2) and Without (Period 1) SYN-004.
Period 1
|
464,400.0 h*ng/mL
Standard Deviation 26,884.9
|
656,200.0 h*ng/mL
Standard Deviation 105,257.8
|
|
Ceftriaxone PK Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) With (Period 2) and Without (Period 1) SYN-004.
Period 2
|
478,800.0 h*ng/mL
Standard Deviation 37,117.4
|
643,800.0 h*ng/mL
Standard Deviation 108,349.9
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=6 participants at risk
1 g ceftriaxone and two low doses of SYN-004
|
High Dose
n=5 participants at risk
1 g ceftriaxone and two high doses of SYN-004
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6
|
0.00%
0/5
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6
|
0.00%
0/5
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6
|
20.0%
1/5
|
|
Nervous system disorders
Headache
|
16.7%
1/6
|
40.0%
2/5
|
|
General disorders
Catheter site bruise
|
16.7%
1/6
|
0.00%
0/5
|
|
General disorders
Discomfort
|
16.7%
1/6
|
0.00%
0/5
|
|
General disorders
Feeling cold
|
16.7%
1/6
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
20.0%
1/5
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
|
20.0%
1/5
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6
|
0.00%
0/5
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
16.7%
1/6
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6
|
20.0%
1/5
|
|
Vascular disorders
Hot flush
|
16.7%
1/6
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators do not see trial results ahead of public disclosure unless it is under CDA. Investigators will not be allowed to publish or disclose any study results prior to sponsor communicating it to the public.
- Publication restrictions are in place
Restriction type: OTHER