A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of REC-3964 in Healthy Subjects
- Conditions
- Clostridium difficileBacterial infection in the bowel10004018
- Registration Number
- NL-OMON53684
- Lead Sponsor
- Recursion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 106
1. Subject is male or female aged >= 18 to <= 65 years. For Cohort A6 and
potentially for Cohort B5, subject is male or female aged > 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of single ascending doses (SAD) and<br /><br>multiple ascending doses (MAD) of REC-3964 administered orally to healthy<br /><br>subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objectives:<br /><br>• To characterize the pharmacokinetics (PK) of REC-3964 and its enantiomer,<br /><br>REC-3974, in plasma and urine following single and multiple oral doses of<br /><br>REC-3964 in healthy subjects.<br /><br><br /><br>Exploratory Objectives:<br /><br>• To investigate the metabolite profile of REC-3964 in plasma following single<br /><br>and multiple oral doses of REC-3964 in healthy subjects.<br /><br>• To investigate the potential genetic variants influencing the PK of REC-3964<br /><br>in healthy subjects.<br /><br>• To investigate potential blood biomarkers of REC-3964 activity following<br /><br>single and multiple oral doses in healthy subjects.<br /><br>• To evaluate changes in cytochrome P450 (CYP)3A activity following multiple<br /><br>oral doses of REC-3964 in healthy subjects.<br /><br>• To estimate the fraction of unbound REC-3964 in plasma following single oral<br /><br>doses of REC-3964 in healthy subjects. </p><br>