NCT02419001

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2015

Typical duration for phase_1 healthy-volunteers

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 11, 2017

Completed
Last Updated

November 27, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

April 1, 2015

Results QC Date

November 15, 2016

Last Update Submit

October 31, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.

    2 weeks

  • Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.

    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.

    2 weeks

  • 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.

    2 weeks

Study Arms (4)

Period 1 - Treatment Sequence AB

EXPERIMENTAL

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

Drug: Period 1 - Treatment Sequence AB

Period 1 - Treatment Sequence AC

EXPERIMENTAL

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

Drug: Period 1 - Treatment Sequence AC

Period 2 - Treatment Sequence AB

EXPERIMENTAL

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

Drug: Period 2 - Treatment Sequence AB

Period 2 - Treatment Sequence AC

EXPERIMENTAL

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

Drug: Period 2 - Treatment Sequence AC

Interventions

Period 1 - Treatment Sequence ABDRUG

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

Period 1 - Treatment Sequence AB
Period 1 - Treatment Sequence ACDRUG

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

Period 1 - Treatment Sequence AC
Period 2 - Treatment Sequence ABDRUG

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

Also known as: ribaxamase
Period 2 - Treatment Sequence AB
Period 2 - Treatment Sequence ACDRUG

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

Also known as: ribaxamase
Period 2 - Treatment Sequence AC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has a functioning ileostomy which has been in place for \> 3 months.
  • Male or female between the ages of 18 and 70 years, inclusive.
  • Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease.

You may not qualify if:

  • Subjects who have active hepatic, small intestine, or biliary tract disease.
  • Subjects who have active ulcerative colitis, Crohn's disease, other inflammatory bowel disease.
  • Subjects with known malignancy requiring treatment \< 6 months prior to study screening.
  • Subjects who have, in the opinion of the investigator, significant concurrent medical illness.
  • Subjects who are currently taking concomitant medications which may interfere with study evaluation.
  • 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.
  • Subjects with a known history of allergy to any cephalosporin, penicillin or any β-lactam antibiotic.
  • Subjects who have known active malabsorption syndromes(s) that, in the judgment of the investigator, could compromise the objectives of the study.
  • Subjects who have used any oral, intramuscular, or IV anti-microbial medication during the last 3 weeks prior to the screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Columbus, Ohio, 43210, United States

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Montreal, Canada

Location

Related Publications (1)

  • Kokai-Kun JF, Roberts T, Coughlin O, Sicard E, Rufiange M, Fedorak R, Carter C, Adams MH, Longstreth J, Whalen H, Sliman J. The Oral beta-Lactamase SYN-004 (Ribaxamase) Degrades Ceftriaxone Excreted into the Intestine in Phase 2a Clinical Studies. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e02197-16. doi: 10.1128/AAC.02197-16. Print 2017 Mar.

    PMID: 28052855DERIVED

Results Point of Contact

Title
Michael Kaleko
Organization
Synthetic Biologics Inc.
mkaleko@syntheticbiologics.com
(240) 238-3862

Study Officials

  • Michael Kaleko, M.D.

    Synthetic Biologics

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 17, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

November 27, 2018

Results First Posted

January 11, 2017

Record last verified: 2018-10

Locations

US(1)CA(2)