Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypa… (NCT05377112) | Clinical Trial Compass
CompletedEarly Phase 1
Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
United States11 participantsStarted 2022-03-29
Plain-language summary
Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome. In addition, this study will explore other PD effects relative to baseline as well as predictors of efficacy and tolerability.
Who can participate
Age range18 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 to ≤ 74 years.
* Able and willing to voluntarily complete the informed consent process.
* Available for, and agree to, all study procedures, including fixed diet, feces, urine, and blood
* collection, follow-up visits, and compliance with all study procedures.
* History of gastric bypass surgery (at least 12 months prior to Day 1) or short-bowel
* syndrome.
* If taking probiotic supplements (enriched foods excluded), has been on a stable, well tolerated dose for at least 2 weeks prior to Day 1.
* Women of childbearing potential must have a negative pregnancy test (human chorionic
* gonadotropin) at screening and at baseline prior to the start of IMP.
* Screening laboratory evaluations (e.g., chemistry panel, complete blood count with
* differential, prothrombin time, urinalysis) and electrocardiogram (ECG) must be within
* normal limits or judged not to be clinically significant by the investigator. Subjects with
* known diabetes should be well controlled and have an A1c of ≤ 8% within 3 months prior to Day 1.
* Agree to abstain from tobacco/nicotine use for the duration of the inpatient stay.
* Subjects who are HIV positive, on therapy with normal CD4 counts and undetectable viral loads, can be included.
Exclusion Criteria:
* Acute or chronic medical (including COVID-19 infection), surgical, psychiatric, or social condition or laboratory abnormality (except those that can be explained by malabsorption) that may increase subject risk associat…
What they're measuring
1
Safety and tolerability of SYNB8802v1, as assessed by measuring of vital signs
Timeframe: 17 days
2
Safety and tolerability of SYNB8802v1 by assessing clinical laboratory tests
Timeframe: 17 days
3
Safety and tolerability of SYNB8802v1, as assessed by AEs, clinical laboratory tests, and vital sign measurements