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Trial record 88 of 3118 for:    Area Under Curve AND Healthy

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

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ClinicalTrials.gov Identifier: NCT01862939
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2013
First Posted Date  ICMJE May 27, 2013
Last Update Posted Date May 27, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
determine blood concentrations of DS-7309 [ Time Frame: 48 hours ]
The plasma pharmacokinetic (PK) parameters of A203-5319 (the free form of DS-7309) and relevant metabolite of DS-7309 in healthy subjects and subjects with T2DM.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: DS-7309
    1, 2.5, 5, 10, 20 mg DS-7309 powder in bottle.
  • Drug: placebo
    placebo to match part 2 DS-7309
Study Arms  ICMJE
  • Experimental: part 1 DS-7309 ascending dose
    1, 2.5, 5, 10, 20 mg blinded DS-7309 powder in bottle.
    Intervention: Drug: DS-7309
  • Experimental: part 2 DS-7309
    1, 2.5, 5, and 15mg DS-7309 powder in bottle for oral solution.
    Intervention: Drug: DS-7309
  • Placebo Comparator: part 2 placebo
    placebo to match part 2 DS-7309
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2013)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women must be of non-child bearing potential, ie, either:

    1. Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing), or
    2. 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.
  • Diagnosis of type 2 diabetes mellitus for a minimum of 3 months prior to first dose.
  • Body Mass Index (BMI) of 19.00 to 40.00 kg/m2 inclusive.
  • Subjects should be either:

    1. Treatment naïve from any antidiabetic treatment for at least 6 months prior to screening with a hemoglobin A1c (HBA1c) value between 7%-10%, inclusive.
    2. On metformin alone with a HBA1c value between 7%-9%, inclusive, and willing to discontinue current metformin treatment for at least 2 weeks prior to study and during the duration of the study. See Section 9.10.1 for monitoring during 2 week washout.

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 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.
  • Relationship of the subject to the Investigator, any sub-investigator, pharmacist, study coordinator, or other staff directly involved in the conduct of the study, or employment by the Sponsor or contract research organization participating in the study.
  • Familial relationship of the subject to any subjects previously or currently enrolled in the study.
  • Screening laboratory values outside the range of normal values that are deemed clinically significant by the Investigator. Liver function tests (AST, ALT, total bilirubin, and lactate dehydrogenase [LDH]) must be at or below the ULN. If a subject has a non-clinically significant high abnormal reading for one or more of the liver function tests on the screening lab test, the test may be repeated once. If the lab test results are normal on the repeat test, he/she may be enrolled provided the Day -1 lab test results are also normal.
  • Hemoglobin levels below the lower limit of normal of the clinical laboratory's reference range at the screening visit.
  • Enrollment in a prior dose cohort of this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01862939
Other Study ID Numbers  ICMJE DS7309-A-U101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP