Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects

Part of paid clinical trials in Austin, Texas.

Sponsor
AstraZeneca
Study ID
NCT01135446
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • dapagliflozin — DRUG
    Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
  • dapagliflozin — DRUG
    Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
  • dapagliflozin — DRUG
    Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
  • dapagliflozin — DRUG
    Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
  • dapagliflozin — DRUG
    Tablets, Oral, 1 mg, once on Day 1 only, 2 days
  • dapagliflozin — DRUG
    Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days

Study Details

The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.

Key Dates

Start date
May 31, 2010
Status verified
Oct 2016
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL

Arms

  • Experimental: dapagliflozin (0.001 mg)
    Cohort 1
  • Experimental: dapagliflozin (0.01 mg)
    Cohort 2
  • Experimental: dapagliflozin (0.1 mg)
    Cohort 3
  • Experimental: dapagliflozin (0.3 mg)
    Cohort 4
  • Experimental: dapagliflozin (1 mg)
    Cohort 5
  • Experimental: dapagliflozin (2.5 mg)
    Cohort 6

Primary Outcome Measure

Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect [ Time Frame: 24 hours after dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ppd Development, LpAustinTexas78744-

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