Colon cancer Colon cancer
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single ascending doses (SADs) of orally administered REC-4881 in healthy adult volunteers. | — |
Secondary
| Measure | Time 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