A 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

NCT01862939 | Completed Phase 1

• 1 other identifier: DS7309-A-U101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• incremental area under the curve (IAUC) blood glucose

  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).

  5 hours

Secondary Outcomes (1)

• determine blood concentrations of DS-7309

  48 hours

Study Arms (3)

part 1 DS-7309 ascending dose

EXPERIMENTAL

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

Drug: DS-7309

part 2 DS-7309

EXPERIMENTAL

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

Drug: DS-7309

part 2 placebo

PLACEBO COMPARATOR

placebo to match part 2 DS-7309

Drug: placebo

Interventions

DS-7309 DRUG

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

part 1 DS-7309 ascending dose; part 2 DS-7309

placebo DRUG

placebo to match part 2 DS-7309

part 2 placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Healthy women who are not of childbearing potential and men, 18 to 45 years of age, inclusive.
• Body Mass Index (BMI) of 19.00 to 32.00 kg/m2 inclusive.
• Good health, as determined by the absence of clinically significant deviation from normal, based on medical history, physical examination, laboratory reports, and 12-lead ECG, as deemed by the Investigator, prior to enrollment.
• Baseline (0 hour) pre-dose capillary blood glucose ≥ 70 mg/dL. Part 2 (T2DM subjects)
• Women who are not of childbearing potential and men, 18 to 55 years of age, inclusive.

You may not qualify if:

• 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 1.
• 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.
• Subjects with any history of arrhythmia.
• Significant blood donation or significant blood loss within the 56 days before Day -1.
• Plasma donation within 7 days before Day -1.
• Participation in another investigational new drug research study within the 30 days before Day 1.
• Use of tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within the 6 months before Day 1.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

US (1)