PK study of novel Tadalafil formulations in healthy males (QCL118085)
Research type
Research Study
Full title
A Phase 1 Study in Healthy Male Subjects to Evaluate and Compare the Pharmacokinetics of Single Oral Doses of Novel Tadalafil Oral Immediate Release formulations and a Cialis Reference Tablet
IRAS ID
232775
Contact name
Katalin Ferenczi
Contact email
Sponsor organisation
Druggability Technologies Holdings Ltd
Eudract number
2017-003123-30
Duration of Study in the UK
0 years, 2 months, 15 days
Research summary
The Sponsor is developing a new formulation (recipe) of the study drug, tadalafil, for the treatment of erectile dysfunction (impotence or the inability to maintain an erection). The study drug tadalafil is currently available for use in patients as a marketed tablet called Cialis.\n\nThe study will identify the level of the study drug present in the blood after receiving a single dose of the new tadalafil formulation, compared to the currently available tablet Cialis. The safety and tolerability of the new tadalafil formulation will also be assessed. \n\nThe study will consist of 1 part involving up to 12 healthy male subjects. The subjects will attend the clinical unit on up to 4 occasions for Periods 1-4 (with Periods 3 and 4 being optional), to receive one of four treatment Regimens (A-D), with Regimens C and D being optional regimens. Regimen A will be a single dose of 20 mg of Cialis reference tablet. Regimen B will be a single dose of 10 mg of the new tadalafil tablets (2 × 5 mg). After Periods 1 and 2 are complete, a period of interim review will be performed to determine if Periods 3 and 4 are required, and the dose and formulation to be administered. Optional Regimens C and D will be a single dose of the new tadalafil formulation; either as tablets by mouth or a liquid medicine (tablets dispersed in water) swallowed by mouth. Each study period will follow the same study design, subjects will be dosed on Day 1 and will remain in clinic until 48 hours post-dose to perform blood samples and safety assessments. The subjects will return to the clinic at 72 hours (Day 4) and 96 hours (Day 5) post-dose for a blood sample. There will be a minimum of 7 days between each product administration.\n
REC name
HSC REC A
REC reference
17/NI/0176
Date of REC Opinion
3 Oct 2017
REC opinion
Favourable Opinion