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A Randomized, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of REC-4881 in Healthy Volunteers

A Randomized, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of REC-4881 in Healthy Volunteers - SAD and FE study to assess the safety, tolerability, PK and PD of REC-4881

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51761
Enrollment
24
Registered
2022-01-25
Start date
2022-02-10
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer Colon cancer

Interventions

Group 1: Treatment 4 mg REC-4881 once or placebo (with food or fasting) Days 1 and 15 8 mg REC-4881 once or placebo (with food or fasted) Day 29 Group 2: Treatment 4 mg REC-4881 once or placebo (wi

Sponsors

Recursion Pharmaceuticals, Inc.
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and tolerability of single ascending doses (SADs) of orally administered REC-4881 in healthy adult volunteers.

Secondary

MeasureTime frame
To characterize the plasma pharmacokinetics (PK) of SADs of orally administered REC-4881 and REC 1157786 (its enantiomer) in healthy adult volunteers. To evaluate the effect of food on the single-dose PK of REC-4881 and REC 1157786.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)