Healthy VolunteersPhase 1/2NCT02419001
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
A Phase 1/2 study testing Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC and Period 2 - Treatment Sequence AB in people with Healthy Volunteers, run by Theriva Biologics, Inc. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC and Period 2 - Treatment Sequence AB
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2015to Oct 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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
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.
Read the detailed 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.
- Conditions
- Healthy Volunteers
- Being tested
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, Period 2 - Treatment Sequence AB, Period 2 - Treatment Sequence AC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1 - Treatment Sequence ABDrug
Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
Period 1 - Treatment Sequence ACDrug
Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
Period 2 - Treatment Sequence ABDrug
Also called ribaxamase
Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg
Period 2 - Treatment Sequence ACDrug
Also called ribaxamase
Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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] Receives: 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 Receives: 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 Receives: Drug: Period 2 - Treatment Sequence AC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theriva Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kaleko, M.D., Study chair, Synthetic Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419001
- Sponsor's protocol ID
- SB-1-004-003
- Status last verified
- Oct 2018
- First submitted
- 1 Apr 2015
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28052855
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02419001
- Acronym / sponsor ID
- SB-1-004-003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Theriva Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Posted 11 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1 - Treatment Sequence AB | Experimental | Drug: Period 1 - Treatment Sequence ABTreatment 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] |
| Period 1 - Treatment Sequence AC | Experimental | Drug: 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] |
| Period 2 - Treatment Sequence AB | Experimental | Drug: Period 2 - Treatment Sequence ABTreatment 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 |
| Period 2 - Treatment Sequence AC | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Period 1 - Treatment Sequence ABPeriod 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 | Drug | Period 1 - Treatment Sequence AB |
| Period 1 - Treatment Sequence ACPeriod 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 | Drug | Period 1 - Treatment Sequence AC |
| Period 2 - Treatment Sequence ABAlso: ribaxamasePeriod 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg | Drug | Period 2 - Treatment Sequence AB |
| Period 2 - Treatment Sequence ACAlso: ribaxamasePeriod 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg | Drug | Period 2 - Treatment Sequence AC |
Primary outcome
Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.
Time frame: 2 weeks
Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.
Time frame: 2 weeks
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28052855Kokai-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kaleko, M.D. study chair
Synthetic Biologics
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC and Period 2 - Treatment Sequence AB in people with Healthy Volunteers, run by Theriva Biologics, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004. (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.