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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Period 1 - Treatment Sequence AB

Treatment Sequence AB:

* Period 1: Ceftriaxone 1 g infused IV over 30 minutes
* \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\]

Group Type EXPERIMENTAL

Period 1 - Treatment Sequence AB

Intervention Type DRUG

Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004

Period 1 - Treatment Sequence AC

* Period 1: Ceftriaxone 1 g infused IV over 30 minutes
* \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\]

Group Type EXPERIMENTAL

Period 1 - Treatment Sequence AC

Intervention Type DRUG

Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004

Period 2 - Treatment Sequence AB

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

Group Type EXPERIMENTAL

Period 2 - Treatment Sequence AB

Intervention Type DRUG

Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg

Period 2 - Treatment Sequence AC

* \[Period 1: Ceftriaxone 1 g infused IV over 30 minutes\]
* 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

Group Type EXPERIMENTAL

Period 2 - Treatment Sequence AC

Intervention Type DRUG

Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg

Interventions

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Period 1 - Treatment Sequence AB

Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004

Intervention Type DRUG

Period 1 - Treatment Sequence AC

Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004

Intervention Type DRUG

Period 2 - Treatment Sequence AB

Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg

Intervention Type DRUG

Period 2 - Treatment Sequence AC

Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg

Intervention Type DRUG

Other Intervention Names

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ribaxamase ribaxamase

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes