Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of KUC 7483 CL Tablets in Healthy Male Volunteers

NCT02259764 | Completed Phase 1

• 1 other identifier: 1207.6
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of subjects with abnormal findings in physical examination

  up to 8 days after last drug administration

• Number of subjects with abnormal changes in laboratory parameters

  special parameters, Tropanin I, insulin, C-Peptide, glucagon, free fatty acids, lactate, potassium, cAMP and faecal occult blood testing

  up to 8 days after last drug administration

• Number of subjects with clinically significant changes in vital signs

  Blood Pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing

  up to 8 days after last drug administration

• Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)

  up to 8 days after last drug administration

• Number of subjects with adverse events

  up to 8 days after last drug administration

• Assessment of tolerability by investigator on a 4-point scale

  8 days after last drug administration

Secondary Outcomes (12)

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 48 hours after drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 48 hours after drug administration

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 48 hours after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  up to 48 hours after drug administration

• λ z (terminal rate constant of the analyte in plasma)

  up to 48 hours after drug administration

Study Arms (2)

KUC 7483 CL - single rising dose

EXPERIMENTAL

Treatment 1: KUC 7483 CL - low dose Treatment 2: KUC 7483 CL - medium dose Treatment 3: KUC 7483 CL - high dose In treatment 3 the same subjects as in treatment 2 received drug immediately after the ingestion of a standardized high fat meal

Drug: KUC 7483 CL - single rising dose; Other: standardized high fat meal

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KUC 7483 CL - single rising dose DRUG

KUC 7483 CL - single rising dose

Placebo DRUG

Placebo

standardized high fat meal OTHER

KUC 7483 CL - single rising dose

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥ 30 and Age ≤ 60 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: August 1, 2004
• Primary Completion: September 1, 2004
• Last Updated: October 9, 2014

Record last verified: 2014-10