Safety, Tolerability and Pharmacokinetics of Single Rising Doses of YF476, a Gastrin Antagonist, in Healthy Men
|ClinicalTrials.gov Identifier: NCT01538784|
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : February 24, 2012
The objectives of the study were:
- To assess the safety, tolerability and pharmacokinetics of YF476 in healthy volunteers.
- To select a dose or doses of YF476 for detailed pharmacodynamic studies in healthy volunteers.
|Condition or disease||Intervention/treatment||Phase|
|Reflux Oesophagitis||Drug: YF476||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of YF476, a Novel, Potent and Selective Gastrin/Cholecystokinin-B Antagonist, in Healthy Male Volunteers|
|Study Start Date :||May 1996|
|Primary Completion Date :||June 1996|
|Study Completion Date :||June 1996|
Two groups of six subjects received single rising oral doses of YF476 capsules or matching placebo. Each subject received 2 doses of YF476 and 1 dose of placebo. 4 subjects received active and 2 placebo at each dose level, as follows:
Group A YF476 0.5, 25 and 100mg by mouth Group B YF476 5.0, 50 and 100mg by mouth
Groups A & B were dosed alternately, at weekly intervals
- Clinically relevant changes from baseline in safety assessments [ Time Frame: 6 weeks ]Physical examination, ECG and safety tests of blood and urine at screening and at 24 hours and 7 days after dosing. ECG, blood pressure and heart rate during study period.
- Numbers of adverse events [ Time Frame: 6 weeks ]Adverse events during study period and at follow-up.
- Pharmacokinetic parameters: Cmax, Tmax, AUC 0-24 h, T1/2 [ Time Frame: 6 weeks ]
Blood samples (10 mL) for assay of YF476 at 0, 0.25, 0.5, 0.75, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours after dosing.
Urine collection: 0-6, 6-12 and 12-24 hours after dosing.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538784
|Hammersmith Medicines Research|
|London, United Kingdom, NW10 7EW|
|Study Director:||Malcolm J Boyce, FRCP FFPM||Trio Medicines Limited|