A Single Ascending Dose Study of PCO371 in Healthy Volunteers
Status: | Terminated |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 4/21/2016 |
Start Date: | June 2015 |
End Date: | October 2015 |
A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers
This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study
to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in
healthy adult males.
Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.
to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in
healthy adult males.
Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.
Inclusion Criteria:
- Healthy male volunteers aged 18 to 45 years.
- Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2)
- Able and willing to abide by the protocol
Exclusion Criteria:
- Evidence of any medical condition that could affect renal, hepatic, or
cardiopulmonary functions.
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