Clostridium difficile Bacterial infection in the bowel
Conditions
Interventions
Part A
Starting dose 50 mg REC-3964 or placebo orally once on D1 (doses in subsequent
groups to be determined).
Part B
Starting dose to be determined REC-3964 or placebo orally from D1 to D14: One
Sponsors
Recursion Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is male or female aged >= 18 to 65 years (note: there is no upper limit for the subject*s age). 2. Subject must provide written informed consent prior to initiation of any study procedures. 3. Subject*s body mass index is between 18 and 32 kg/m2, inclusive, with a minimum body weight of 50 kg. 4. Subject is healthy as determined by medical history, physical examination, vital signs, and 12 lead ECG. For any abnormalities, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. 5. Subject*s clinical laboratory test results (hematology including reticulocyte count, biochemistry, coagulation, urinalysis, comprehensive metabolic panel, and complete blood count) are clinically acceptable as determined by the Investigator at Screening and Admission.
Exclusion criteria
Exclusion criteria: 1. Subject has any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, could interfere with the conduct or interpretation of the study or put the subject at risk. 2. Subject has any condition that, in the opinion of the Investigator, could affect drug absorption (eg, stomach or intestinal surgery such as cholecystectomy or bariatric surgery, gastroesophageal reflux disease, irritable bowel syndrome, or celiac disease). 3. Subject has a known history of hypersensitivity to the drug class or its excipients. 4. Subject has a history of alcohol or substance abuse within 1 year prior to screening for study participation, or is currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner, which, in the opinion of the Investigator, indicates abuse. 5. Subject has been treated with prescription, over-the-counter, dietary, or herbal supplements that are CYP3A inhibitors or inducers within 14 days before the first dose of study drug: eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, rifampin, rifapentine, rifabutin, grapefruit juice, Valencia oranges, or St. John*s Wort.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of REC-3964 administered orally to healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: • To characterize the pharmacokinetics (PK) of REC-3964 and its enantiomer, REC-3974, in plasma and urine following single and multiple oral doses of REC-3964 in healthy subjects. Exploratory Objectives: • To investigate the metabolite profile of REC-3964 in plasma following single and multiple oral doses of REC-3964 in healthy subjects. • To investigate the potential genetic variants influencing the PK of REC-3964 in healthy subjects. • To investigate potential blood biomarkers of REC-3964 activity following single and multiple oral doses in healthy subjects. • To evaluate changes in cytochrome P450 (CYP)3A activity following multiple oral doses of REC-3964 in healthy subjects. • To estimate the fraction of unbound REC-3964 in plasma following single oral doses of REC-3964 in healthy subjects. | — |
Countries
Netherlands
Outcome results
None listed