A Phase 1/2 interventional study of SYN-004 and Esomeprazole in Healthy Volunteers With Ileostomy, sponsored by Theriva Biologics, Inc.. Completed at 2 sites in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-27.
Sponsored by Theriva Biologics, Inc. · Phase 1/2, Interventional, and Treatment
A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy
This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects with functioning ileostomies who are between the ages of 18 and 80 years, inclusive, will be enrolled. The entire duration of the study may be up to 63 days (from Screening to the end-of-study [EOS] visit).
Theriva Biologics, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of steady-state esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.
Drug: SYN-004 · Drug: Esomeprazole · Drug: Ceftriaxone
Ceftriaxone Concentration in Intestinal Chyme Period 1
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
Time frame: 0-8.5 hours
Ribaxamase Concentration in Intestinal Chyme Period 1
Concentrations of ribaximase (SYN-004) in intestinal chyme
Time frame: 0-8.5 hours
Ceftriaxone Concentration in Intestinal Chyme Period 2
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
Time frame: 0-8.5 hours
Ribaxamase Concentration in Intestinal Chyme Period 2
Concentrations of ribaximase (SYN-004) in intestinal chyme
Time frame: 0-8.5 hours
| Milestone | 150 mg SYN-004 |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | 150 mg SYN-004 |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
| Milestone | 150 mg SYN-004 |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
| ug/mL | 150 mg SYN-004 |
|---|---|
| Hour 0 | 0.00 ± 0.00 |
| Hour 0.5 | 0.00 ± 0.00 |
| Hour 1.5 | 5.60 ± 4.39 |
| Hour 2.5 | 150.90 ± 68.43 |
| Hour 3.5 | 231.40 ± 144.06 |
| Hour 4.5 | 173.00 ± 98.58 |
| Hour 5.5 | 29.00 ± 25.40 |
| Hour 6.5 | 1.40 ± 0.82 |
| Hour 7.5 | 0.10 ± 0.10 |
| Hour 8.5 | 2.00 ± 1.70 |
Concentrations of ribaximase (SYN-004) in intestinal chyme
| ng/mL | 150 mg SYN-004 |
|---|---|
| Hour 0 | 0.00 ± 0.00 |
| Hour 0.5 | 2 ± 2.1 |
| Hour 1.5 | 11 ± 9.1 |
| Hour 2.5 | 131 ± 116.8 |
| Hour 3.5 | 6727 ± 3983.1 |
| Hour 4.5 | 56795 ± 25155.4 |
| Hour 5.5 | 73090 ± 29292.8 |
| Hour 6.5 | 103171 ± 52510.2 |
| Hour 7.5 | 153274 ± 87804.1 |
| Hour 8.5 | 111946 ± 71722.7 |
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
| ug/mL | 150 mg SYN-004 |
|---|---|
| Hour 0 | 0.00 ± 0.00 |
| Hour 0.5 | 0.00 ± 0.00 |
| Hour 1.5 | 9.80 ± 8.43 |
| Hour 2.5 | 31.70 ± 22.57 |
| Hour 3.5 | 42.80 ± 30.44 |
| Hour 4.5 | 80.50 ± 56.28 |
| Hour 5.5 | 0.80 ± 0.63 |
| Hour 6.5 | 0.10 ± 0.10 |
| Hour 7.5 | 0.00 ± 0.00 |
| Hour 8.5 | 0.20 ± 0.14 |
Concentrations of ribaximase (SYN-004) in intestinal chyme
| ng/mL | 150 mg SYN-004 |
|---|---|
| Hour 0 | 0.00 ± 0.00 |
| Hour 0.5 | 436 ± 435.6 |
| Hour 1.5 | 281 ± 206.6 |
| Hour 2.5 | 97745 ± 74180. |
| Hour 3.5 | 66936 ± 46358.5 |
| Hour 4.5 | 63696 ± 26962.2 |
| Hour 5.5 | 42316 ± 15114.4 |
| Hour 6.5 | 38874 ± 21552.0 |
| Hour 7.5 | 34756 ± 19642.6 |
| Hour 8.5 | 35092 ± 20734.9 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Period 1 | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Run-in Period | 0/14 (0%) | 0/14 (0%) | 3/14 (21.4%) |
| Treatment Period 2 | 0/14 (0%) | 0/14 (0%) | 2/14 (14.3%) |
| Event | Treatment Period 1 | Run-in Period | Treatment Period 2 |
|---|---|---|---|
| Abdominal DiscomfortGastrointestinal disorders | 0/15 | 2/14 | 0/14 |
| HeadacheNervous system disorders | 1/15 | 0/14 | 1/14 |
| Vessel puncture site bruiseGeneral disorders | 0/15 | 0/14 | 1/14 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/15 | 1/14 | 0/14 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/15 | 1/14 | 0/14 |
| NauseaGastrointestinal disorders | 1/15 | 0/14 | 0/14 |
| Stoma site hemorrhageInjury, poisoning and procedural complications | 1/15 | 0/14 | 0/14 |
| Postmenopausal hemorrhageReproductive system and breast disorders | 1/15 | 0/14 | 0/14 |
| ErythemaSkin and subcutaneous tissue disorders | 1/15 | 0/14 | 0/14 |
| Hot flushVascular disorders | 1/15 | 0/14 | 0/14 |
| Age, Continuous(years) | 150 mg SYN-004 |
|---|---|
| Mean | 45.1 ± 16.4 |
| Sex: Female, Male(Participants) | 150 mg SYN-004 |
|---|---|
| Female | 4 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | 150 mg SYN-004 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
The record gives a start of Jun 2015, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2018, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SYN-004
Theriva Biologics, Inc.