NCT02470286

A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

A Phase1, Double-blind, Randomized, Placebo-control, Single Center, Single Dose Administration, Dose Escalation Study to Investigate the Pharmacokinetics, Safety and Tolerability of SA001 in Healthy Male Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Samjin Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite in healthy male volunteers.

Detailed description

This study consists of Part 1 followed Part 2. Part 1 (Dose escalation study, SA001 60mg\~300mg dose group) The part 1 is a dose escalation study. The starting dose is SA001 60mg, and the maximum dose is 300mg. Each dose group is assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a single oral administration on the fasting state. Part 2 (Single dose and food effect study, SA001 120mg and 300mg dose group) The purpose of this part 2 is to evaluate the food effect of a high-fat diets(HFDs) on the single oral dose pharmacokinetics of SA001 and its metabolite.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SA001 60mg or Placebo	* Study Drug: SA001 60mg * Comparator: Placebo * Cohort 1 in the part 1 (Dose escalation study)
DRUG	SA001 120mg or Placebo	* Study Drug: SA001 120mg * Comparator: Placebo * Cohort 2 in the part 1 (Dose escalation study) and part 2 (Food effect study)
DRUG	SA001 180mg or Placebo	* Study Drug: SA001 180mg * Comparator: Placebo * Cohort 3 in the part 1 (Dose escalation study)
DRUG	SA001 240mg or Placebo	* Study Drug: SA001 240mg * Comparator: Placebo * Cohort 4 in the part 1 (Dose escalation study)
DRUG	SA001 300mg or Placebo	* Study Drug: SA001 300mg * Comparator: Placebo * Cohort 5 in the part 1(Dose escalation study) and part 2 (Food effect study)

Timeline

• Start date: 2015-06-29
• Primary completion: 2015-09-18
• Completion: 2015-09-30
• First posted: 2015-06-12
• Last updated: 2022-03-24

Locations

1 site across 1 country: South Korea