Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers

Sponsor
Daewoong Pharmaceutical Co. LTD.
Study ID
NCT03364985
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
19 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • DWP16001 — DRUG
    DWP16001 tablets
  • Placebo — DRUG
    DWP16001 placebo-matching tablets, Active control placebo-matching tablets
  • Dapagliflozin — DRUG
    Forxiga®

Study Details

This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers.

Key Dates

Start date
Dec 3, 2017
Status verified
Aug 2019
Primary completion
May 21, 2019
Completion
Jul 30, 2019

Study Design

Enrollment
123 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: DWP16001 Amg
    DWP16001 Amg, tablets, orally, single dose administration
  • Experimental: Cohort 2: DWP16001 Bmg
    DWP16001 Bmg, tablets, orally, single dose administration
  • Experimental: Cohort 3: DWP16001 Cmg
    DWP16001 Cmg, tablets, orally, single dose administration
  • Experimental: Cohort 4: DWP16001 Dmg
    DWP16001 Dmg, tablets, orally, single dose administration
  • Experimental: Cohort 5: DWP16001 Emg
    DWP16001 Emg, tablets, orally, single dose administration
  • Experimental: Cohort 6: DWP16001 Fmg
    DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
  • Experimental: Cohort 7: DWP16001 Gmg
    DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
  • Experimental: Cohort 8: DWP16001 Hmg
    DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
  • Experimental: Cohort 9: DWP16001 Img
    DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
  • Experimental: Cohort 10: DWP16001 Jmg
    DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Primary Outcome Measure

Number and percentage of Participants With Adverse Events (AE) [ Time Frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit) ]

Related Studies