A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers
Research type
Research Study
Full title
A Pharmacokinetic Dose Proportionality Study of OPL-002 in Healthy Volunteers
IRAS ID
284325
Contact name
Stephen Smith
Contact email
Sponsor organisation
Oppilan Pharma Ltd.
Eudract number
2020-002451-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
Research Summary
In this study, we evaluate two different formulations suspension and tablet) of OPL-002( 20 mg OPL-002 SDD suspension, 5 mg OPL-002 tablet, and 20 mg OPL-002 tablet). OPL-002 is designed to treat the Inflammatory Bowel Diseases such as Ulcerative Colitis. OPL-002 with reducing the number of Lymphocytes in the circulation,reduces the inflammation. 12 healthy subjects will be dosed in three periods. The aim of the study is to compare the blood concentration, the effect of the drug on human body, safety and tolerability for the two formulations.
Summary of Results
The study was performed to evaluate how the blood levels of drug for 2 different tablet strengths of OPL-002 compared to the blood levels of drug administered in a suspension that was used in previous, initial Phase 1 studies in humans. This information will be used to determine tablet doses for future studies.
Twelve subjects were treated in the study, and each received a sequence of each of the tablet strengths and suspension. The blood levels of drug after dosing with the tablets was 66 - 75% of the blood levels of the drug dosed as the suspension.
Ten participants reported 23 side effects in the study, 9 of those side effects were considered to be potentially caused by the drug. The most common side effect was 3 participants experienced a temporary decrease in their heart rate, a known side effect of OPL-002. Three participants experienced a headache, two participants experienced constipation. All other side effects were experienced by only 1 participant. The study also showed that the the participants’ lymphocyte count, one type of white blood cells in blood, was lowered as expected for this class of drug.
REC name
HSC REC B
REC reference
20/NI/0067
Date of REC Opinion
19 Jun 2020
REC opinion
Further Information Favourable Opinion