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

NCT04242953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-04-21

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer Study

Interventions

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)

Sponsors & Collaborators

  • Sun Pharma Advanced Research Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2022-10-21
Completion
2022-10-21
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04242953 on ClinicalTrials.gov