Phase 2
N=11
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02419001 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004. — 137,800.0; 178,600.0; 143,800.0; 169,200.0 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Period 1 - Treatment Sequence AB (Drug); Period 1 - Treatment Sequence AC (Drug); Period 2 - Treatment Sequence AB (Drug); Period 2 - Treatment Sequence AC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theriva Biologics, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004. |
137,800.0; 178,600.0; 143,800.0; 169,200.0 | — |
| PRIMARY Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004. |
0.5; 0.5; 0.5; 0.5 | — |
| 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. |
464,400.0; 656,200.0; 478,800.0; 643,800.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02419001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.