Expired Study
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Columbus, Ohio 43210


Purpose:

A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.


Study summary:

This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects between the ages of 18 and 80 years, inclusive, with functioning ileostomies were planned to be enrolled. In the first treatment period (Period 1) all subjects received an IV infusion of 1 g ceftriaxone. Subjects had a 3 - 7 day washout period between Period 1 and Period 2. In the second treatment period (Period 2) all subjects received an IV infusion of 1 g ceftriaxone and 2 oral doses of either 75 or 150 mg of SYN-004, according to the randomization schedule, which were administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion.


Criteria:

Inclusion Criteria: 1. The subject has a functioning ileostomy which has been in place for > 3 months. 2. Male or female between the ages of 18 and 70 years, inclusive. 3. Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease. Exclusion Criteria: 1. Subjects who have active hepatic, small intestine, or biliary tract disease. 2. Subjects who have active ulcerative colitis, Crohn's disease, other inflammatory bowel disease. 3. Subjects with known malignancy requiring treatment < 6 months prior to study screening. 4. Subjects who have, in the opinion of the investigator, significant concurrent medical illness. 5. Subjects who are currently taking concomitant medications which may interfere with study evaluation. 6. Subjects who have received an investigational drug within 30 days or within a time period consistent with a washout period of 5 half-lives, whichever is longer, of the first dose of ceftriaxone. 7. Subjects with a known history of allergy to any cephalosporin, penicillin or any β-lactam antibiotic. 8. Subjects who have known active malabsorption syndromes(s) that, in the judgment of the investigator, could compromise the objectives of the study. 9. Subjects who have used any oral, intramuscular, or IV anti-microbial medication during the last 3 weeks prior to the screening visit.


Study is Available At:


Original ID:

SB-1-004-003


NCT ID:

NCT02419001


Secondary ID:


Study Acronym:


Brief Title:

A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy


Official Title:

A Phase 1b/2a, Randomized, Multi-center, Open-label, Fixed-sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects With a Functioning Ileostomy


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Synthetic Biologics Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Kaleko, M.D.
Study Chair
Synthetic Biologics

Study Dates

Start Date:March 2015
Completion Date:October 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 31, 2018
First Received Date:April 1, 2015
First Results Date:November 15, 2016

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Time Frame:2 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.
Time Frame:2 weeks
Safety Issues:False
Description:Samples 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 Type:Primary Outcome
Measure:Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.
Time Frame:2 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Period 1 - Treatment Sequence AB
Description:Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
Arm Name:Period 1 - Treatment Sequence AB
Intervention Type:Drug
Name:Period 1 - Treatment Sequence AC
Description:Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
Arm Name:Period 1 - Treatment Sequence AC
Intervention Type:Drug
Name:Period 2 - Treatment Sequence AB
Description:Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg
Arm Name:Period 2 - Treatment Sequence AB
Other Name:ribaxamase
Intervention Type:Drug
Name:Period 2 - Treatment Sequence AC
Description:Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg
Arm Name:Period 2 - Treatment Sequence AC
Other Name:ribaxamase

Study Arms

Study Arm Type:Experimental
Arm Name:Period 2 - Treatment Sequence AC
Description:[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
Study Arm Type:Experimental
Arm Name:Period 2 - Treatment Sequence AB
Description:Treatment Sequence AB: [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
Study Arm Type:Experimental
Arm Name:Period 1 - Treatment Sequence AC
Description: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]
Study Arm Type:Experimental
Arm Name:Period 1 - Treatment Sequence AB
Description:Treatment Sequence AB: 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]

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Synthetic Biologics Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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