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Completed

NCT Number: NCT01386541

Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nycomed Investigational site

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BYK324677

Drug

capsules, administered orally

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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).

  2. 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)

    Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2011
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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