A Phase 1/2 interventional study of Period 1 - Treatment Sequence AB and Period 1 - Treatment Sequence AC in Healthy Volunteers, sponsored by Theriva Biologics, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 70 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, 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.
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.
Theriva Biologics, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
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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.
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: 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
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
* \[Period 1: Ceftriaxone 1 g infused IV over 30 minutes\] * 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
Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg
Also known as: ribaxamase
Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg
Also known as: ribaxamase
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.
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.
Time frame: 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.
Time frame: 2 weeks
| Milestone | Low Dose | High Dose |
|---|---|---|
| Started | 6 | 5 |
| Completed | 5 | 5 |
| Not completed | 1 | 0 |
| Withdrew: Ae w/ ceftriaxone, not dosed w/ ip | 1 | 0 |
| Milestone | Low Dose | High Dose |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
| ng/mL | Treatment Sequence AB | Treatment Sequence AC |
|---|---|---|
| Period 1 | 137,800.0 ± 10,709.8 | 178,600.0 ± 34,623.7 |
| Period 2 | 143,800.0 ± 13,103.4 | 169,200.0 ± 32,782.6 |
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.
| hours | Treatment Sequence AB | Treatment Sequence AC |
|---|---|---|
| Period 1 | 0.5 ± 0.0 | 0.5 ± 0.0 |
| Period 2 | 0.5 ± 0.0 | 0.5 ± 0.0 |
| h*ng/mL | Treatment Sequence AB | Treatment Sequence AC |
|---|---|---|
| Period 1 | 464,400.0 ± 26,884.9 | 656,200.0 ± 105,257.8 |
| Period 2 | 478,800.0 ± 37,117.4 | 643,800.0 ± 108,349.9 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose | — | 0/6 (0%) | 4/6 (66.7%) |
| High Dose | — | 0/5 (0%) | 4/5 (80%) |
| Event | Low Dose | High Dose |
|---|---|---|
| HeadacheNervous system disorders | 1/6 | 2/5 |
| PollakiuriaRenal and urinary disorders | 0/6 | 1/5 |
| Back painMusculoskeletal and connective tissue disorders | 0/6 | 1/5 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/6 | 1/5 |
| Upper respiratory tract infectionInfections and infestations | 0/6 | 1/5 |
| ErythemaSkin and subcutaneous tissue disorders | 0/6 | 1/5 |
| Abdominal painGastrointestinal disorders | 1/6 | 0/5 |
| SomnolenceNervous system disorders | 1/6 | 0/5 |
| Catheter site bruiseGeneral disorders | 1/6 | 0/5 |
| DiscomfortGeneral disorders | 1/6 | 0/5 |
| Age, Continuous(years) | Low Dose | High Dose | Total |
|---|---|---|---|
| Mean | 41.3 ± 11.9 | 57.1 ± 11.6 | 48.5 ± 13.8 |
| Sex: Female, Male(Participants) | Low Dose | High Dose | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 5 | 3 | 8 |
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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Theriva Biologics, Inc.