Safety, Tolerability and Pharmacokinetics of Single Rising Doses of YF476, a Gastrin Antagonist, in Healthy Men
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|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|
|Actual Primary Completion Date :||June 1996|
|Actual Study Completion Date :||June 1996|
- Drug: YF476
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|