NCT04242953

Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in Healthy Male and Post-menopausal Female Subjects

A Multipart Phase 1 Study to Determine Safety, Tolerability and Pharmacokinetics of SCO-120 in Healthy Male and Post-menopausal Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This is a Multipart Phase 1 Randomized, Double blind and Placebo controlled Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in healthy male and postmenopausal female volunteers.

Detailed description

Part A- approximately 76 (Approximately 8 sequential cohorts of 8 subjects per cohort) Part B- Up to approximately, 32 healthy males or post-menopausal female subjects will be enrolled Part C- Approximately 32 healthy male or postmenopausal female subjects (4 sequential cohorts of 8 subjects) will be enrolled

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	SCO-120	Part A: single oral administration Part B: single oral administration in Period 1 and Period 2 (crossover design) Part C: multiple oral administration (14 day dosing)
DRUG	matching placebo	Part A: single oral administration Part C: multiple oral administration (14 day dosing)

Timeline

• Start date: 2020-03-04
• Primary completion: 2022-10-21
• Completion: 2022-10-21
• First posted: 2020-01-27
• Last updated: 2023-04-21

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study