Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nycomed

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