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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419001
• Other study ID #: SB-1-004-003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2018
• Source: Synthetic Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Period 1 - Treatment Sequence AB
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 only, no SYN-004
• Period 2 - Treatment Sequence AB
Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg
• Period 2 - Treatment Sequence AC
Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synthetic Biologics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.		2 weeks
Primary	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
Primary	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