A Randomized, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of REC-4881 in Healthy Volunteers
- Conditions
- Colon cancer
- Registration Number
- NL-OMON51761
- Lead Sponsor
- Recursion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Male or female participant aged 18 to 50 years, inclusive.
2. Participant must provide written informed consent.
3. Participant's body mass index is between 18 and 32 kg/m2, inclusive, with a
minimum body weight of 50 kg.
4. Participant is healthy, as determined by pre-study medical history,physical
examination (including neurologic examination), vital signs, and 12-lead ECG.
1. Participant 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 participant at risk.
2. Participant has a history of gall bladder disorder or complication,
including cholelithiasis.
3. Participant has a history of abnormal left ventricular ejection fraction.
4. Participant has a history of corneal erosions, corneal degenerations, active
or recurrent keratitis, and other forms of serious ocular surface inflammatory
conditions.
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 (SADs) of<br /><br>orally administered REC-4881 in healthy adult volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To characterize the plasma pharmacokinetics (PK) of SADs of orally administered<br /><br>REC-4881 and REC 1157786 (its enantiomer) in healthy<br /><br>adult volunteers.<br /><br>To evaluate the effect of food on the single-dose PK of REC-4881 and REC<br /><br>1157786.</p><br>