Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

NCT01386541 | Completed Phase 1

• 2 other identifiers: B5-8012-101-RD2010-023857-12
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.

  during Treatment Period 1 and Period 2 (up to 3 weeks)

• Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.

  during Treatment Period 1 and Period 2 (up to 3 weeks)

Study Arms (2)

BYK324677

ACTIVE COMPARATOR

* 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.

Drug: BYK324677

Placebo

PLACEBO COMPARATOR

Drug: BYK324677

Interventions

BYK324677 DRUG

capsules, administered orally

BYK324677; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nycomed: lead

Study Sites (1)

Nycomed Investigational site

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

DE (1)