Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

NCT ID: NCT01386541

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-11-30

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

BYK324677

Intervention Type: DRUG

capsules, administered orally

Placebo

Group Type: PLACEBO_COMPARATOR

BYK324677

Intervention Type: DRUG

capsules, administered orally

Interventions

BYK324677

capsules, administered orally

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nycomed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nycomed Investigational site

Mannheim, , Germany

Countries

Germany

Other Identifiers

2010-023857-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B5-8012-101-RD

Identifier Type: -

Identifier Source: org_study_id