NCT02202408

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

A Phase I, Double-blind, Randomized, Placebo-controlled, Single-Dose Escalation, First-in-human Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SKI2670

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. And secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

Detailed description

In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. Secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	SKI2670	Oral, Single Dose
DRUG	Placebo	Same shape as the experimental drug

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-07-29
• Last updated: 2017-10-20

Locations

1 site across 1 country: South Korea