Healthy Volunteer Study to Evaluate Novel Sirolimus Formulation 117958
Research type
Research Study
Full title
A Phase 1 Single Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of a Novel Sirolimus Powder in Bottle Formulation in Healthy Subjects
IRAS ID
221248
Contact name
Katalin Ferenczi
Contact email
Sponsor organisation
Druggability Technologies Holdings Ltd
Eudract number
2016-005018-23
Duration of Study in the UK
0 years, 3 months, 14 days
Research summary
The Sponsor is developing a new formulation of the study drug, Sirolimus (Powder in Bottle formulation). Sirolimus is given to patients who have received a transplant kidney, to stop their body rejecting the new kidney. It can also be used to treat some types of cancer when given in higher doses. This trial will be the first time the new formulation is given to humans.
The study will try to identify if changes in the formulation of the study drug will have a notable effect on the absorption of the study drug and quantity of active ingredient available in the body. The safety and tolerability will also be assessed.
The study will consist of up to five treatment regimens involving up to 32 healthy male and female subjects. Cohort A will receive 0.5 mg of the novel sirolimus powder in bottle formulation. Cohort B will receive 2 mg of the novel sirolimus powder in bottle formulation. Cohort C will receive 10 mg of the novel sirolimus powder in bottle formulation. Cohort D will receive the study drug on two occasions. They will either receive two different dose strengths (10, 20, 30 or 40 mg) or will receive the same dose strength in the fasted and fed state. This will be determined based on emerging data from earlier cohorts. Three hours before each cohort is given the study drug they will be given a famotidine tablet to decrease the acidity of the stomach.
For each dosing period subjects will enter the clinical unit the day before dosing and will remain resident for 48 hours after dosing. Blood samples for analysis of the level of study drug in the blood will be taken at regular intervals during this time.
REC name
HSC REC B
REC reference
17/NI/0023
Date of REC Opinion
21 Feb 2017
REC opinion
Favourable Opinion