Ethnic Bridging

Clinilabs, a contract research organization (CRO), was selected to characterize the pharmacokinetic prole of XXXX following the administration of four doses of XXXX to healthy Japanese and non-Japanese subjects aged 20 to 45 years by assessing serum concentration data over time.

Up to 100 subjects (50 per group) are planned to be enrolled, with up to 10 subjects/group per dose level completing the study. Clinilabs enrolled 11 Japanese and 11 Caucasian subjects in the trial in 12 weeks, exceeding our initial target enrollment. Based on our performance, the sponsor requested that we enroll 6 additional subjects.

The sponsor faced several challenges to study enrollment that they turned to Clinilabs to overcome

• The study was initiated in the Winter when recruiting Japanese subjects typically is more dicult.
• Subject matching was required (a Japanese and a Caucasian subject had to be paired based on gender and smoker status [smoker vs. non-smoker]).
• Japanese subjects had to be born in Japan, with Japanese parents and grandparents, and have lived less than 5 years outside of Japan.