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Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT01386541
First received: June 28, 2011
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: BYK324677
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Safety/Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Doses of BYK324677 in Healthy Volunteers. A Monocentre, Placebo-controlled, Cross-over, Double-blind, Randomised Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

Primary Outcome Measures:
  • Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers. [ Time Frame: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks) ] [ Designated as safety issue: No ]
    Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ [=PR], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis.


Secondary Outcome Measures:
  • Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers. [ Time Frame: during Treatment Period 1 and Period 2 (up to 3 weeks) ] [ Designated as safety issue: No ]
    Pharmacokinetic variables (e.g. AUC, Cmax, tmax, t1/2) of BYK324677 on Day 1 and Day 5 (single dose i.e. after first Investigational medicinal product (IMP) dose vs steady state) as well as on Day 4 and Day 5 (fed vs fasted, respectively).

  • Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers. [ Time Frame: during Treatment Period 1 and Period 2 (up to 3 weeks) ] [ Designated as safety issue: No ]
    Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).


Estimated Enrollment: 36
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BYK324677
  • Dose group I: total daily dose 2 mg (1 mg BID or 2 mg SID)
  • Dose group II: total daily dose 4 mg (2 mg BID or 4 mg SID)
  • Dose group III: total daily dose 6 mg (3 mg BID or 6 mg SID)

In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned.

Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1.

Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner.

 Drug: BYK324677
capsules, administered orally
Placebo Comparator: Placebo Drug: BYK324677
capsules, administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Given written informed consent
  • Healthy male and female subjects. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmHg, diastolic ≤90 mmHg), pulse rate (within 45-95 bpm), ECG assessment, and clinical laboratory results
  • Body mass index (BMI) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg

Exclusion Criteria:

  • History or current evidence of specified diseases
  • History of malignancy in the past 5 years
  • Gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months
  • ECG abnormalities of clinical relevance
  • Suspected hypersensitivity to the trial medication
  • Positive virology tests indicating acute or chronic infections
  • Clinically relevant laboratory parameters outside a specified range
  • Use of specified medications within certain time frames or use of certain co-medications
  • Abuse of alcohol or drugs
  • Dietary habits that would prevent from taking standardised meals
  • Female subjects: positive pregnancy test; lack of medically reliable methods of contraception during the trial
  • Donation of blood
  • Smoking within the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386541

Locations
Germany
Nycomed Investigational site
Mannheim, Germany, 68167
Sponsors and Collaborators
Nycomed: A Takeda Company
  More Information

No publications provided

Responsible Party: Nycomed: A Takeda Company
ClinicalTrials.gov Identifier: NCT01386541     History of Changes
Other Study ID Numbers: B5-8012-101-RD, 2010-023857-12
Study First Received: June 28, 2011
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013