A Double Blind, Placebo-Controlled, Randomized, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus

Daiichi Sankyo1 site in 1 country52 target enrollmentApril 2011

ConditionsType 2 Diabetes Mellitus

InterventionsDS-7309 placebo

DrugsDS-7309 placebo

Overview

Phase: Phase 1
Intervention: DS-7309
Conditions: Type 2 Diabetes Mellitus
Sponsor: Daiichi Sankyo
Enrollment: 52
Locations: 1
Primary Endpoint: incremental area under the curve (IAUC) blood glucose
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.

Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

September 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Daiichi Sankyo

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women must be of non-child bearing potential, ie, either:
•Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing), or
•Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at screening of ≥ 40 mIU/mL.
•All women must have a negative serum pregnancy test at screening and within 48 hours before dosing.
•Able to understand and willing to comply with all study requirements, and willing to follow the study medication regimen.
•Subjects must give written informed consent to participation in the study prior to screening.
•Negative urine test for drugs of abuse and alcohol at screening and check-in.
•Negative result for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody at screening.
•Subjects must agree to abstain from alcohol, cola, tea, coffee, chocolate and other caffeinated drink and food from 2 days before check-in and throughout confinement.
•Subjects must agree to abstain from grapefruit/grapefruit juice and Seville oranges from 10 days before the first dose and throughout the study.

Exclusion Criteria

•Female subject is of childbearing potential, is pregnant (as based on test results) or is breast feeding.
•Male subjects should ensure use of condom and spermicide from dosing until 12 weeks after dosing.
•Male subjects must agree not to donate sperm from dosing until 12 weeks after dosing.
•Any history of drug abuse.
•History of alcohol addiction during the 2 years prior to Day
•History or current evidence, as determined by the Investigator, of psychiatric or emotional problems which would invalidate giving informed consent or limit the ability of the subject to comply with study requirements.
•History or current alcoholic or non-alcoholic liver disease or liver steatosis.
•History of neuropathy.
•Subjects with QTcF interval duration \>450 msec obtained from the ECG taken at screening, after at least 10 minutes of quiet rest in a supine position.
•Subjects with a family history of long QT syndrome.

Arms & Interventions

part 1 DS-7309 ascending dose

1, 2.5, 5, 10, 20 mg blinded DS-7309 powder in bottle.

Intervention: DS-7309

part 2 DS-7309

1, 2.5, 5, and 15mg DS-7309 powder in bottle for oral solution.

Intervention: DS-7309

part 2 placebo

placebo to match part 2 DS-7309

Intervention: placebo

Outcomes

Primary Outcomes

incremental area under the curve (IAUC) blood glucose

Time Frame: 5 hours

The incremental area under the curve (IAUC) of the PD biomarker blood glucose following an oral glucose tolerance test (OGTT) in subjects with type 2 diabetes mellitus (T2DM).