Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386541
• Other study ID #: B5-8012-101-RD
• Secondary ID: 2010-023857-12
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2011
• Last updated: May 4, 2012
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• BYK324677
capsules, administered orally

Locations

Country	Name	City	State
Germany	Nycomed Investigational site	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.	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.	during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)	No
Secondary	Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.	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).	during Treatment Period 1 and Period 2 (up to 3 weeks)	No
Secondary	Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.	Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).	during Treatment Period 1 and Period 2 (up to 3 weeks)	No