Clinical trial NCT01386541: Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2011-07-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
timeFrame: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)
Secondary outcomes:
measure: Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
timeFrame: during Treatment Period 1 and Period 2 (up to 3 weeks)
measure: Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
timeFrame: during Treatment Period 1 and Period 2 (up to 3 weeks)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Nycomed Investigational site
Study officials:
References: