Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes

NCT01282970 | Completed Phase 1

• 2 other identifiers: 1283.22010-022698-32
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of BI 135585 will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, electrocardiograms, laboratory tests, and incidence and severity of adverse events.

  up to 16 days post treatment

Secondary Outcomes (26)

• Assessment of Pharmacokinetic parameter Cmax (maximum measured concentration of the analyte in plasma) of BI 135585 following single and multiple dose oral administration

  up to 10 days post treatment

• Assessment of Pharmacokinetic parameter tmax (time from dosing to maximum measured concentration) of BI 135585 following single and multiple dose oral administration

  up to 10 days post treatment

• Assessment of Pharmacokinetic parameter AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)

  up to 10 days post treatment

• Assessment of Pharmacokinetic parameter λz (terminal rate constant in plasma) of BI 135585 following single and multiple dose oral administration

  up to 10 days post treatment

• Assessment of Pharmacokinetic parameter Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration

  up to 10 days post treatment

Study Arms (2)

BI 135585

EXPERIMENTAL

once daily doses as oral solution or tablet formulation over 14 days

Drug: BI 135585

Placebo to BI 135585

PLACEBO COMPARATOR

once daily doses as oral solution or tablet formulation over 14 days

Drug: Placebo to BI 135585

Interventions

BI 135585 DRUG

oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days

BI 135585

Placebo to BI 135585 DRUG

oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days

Placebo to BI 135585

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and postmenopausal or surgically sterilised female patients with an established diagnosis of type 2 diabetes mellitus prior to informed consent
• Antidiabetic treatment with diet and exercise alone or with not more than one oral hypoglycaemic drug except glitazones, glucagon-like peptide 1 (GLP-1) analogues or dipeptidyl-peptidase 4 (DPP-4) inhibitors.
• Antidiabetic treatment unchanged for 12 weeks prior to informed consent
• Glycosylated haemoglobin A1 (HbA1c) ≤ 8.5% at screening
• Age ≥ 20 and age ≤ 70 years
• BMI ≥ 25 and BMI ≤ 40 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of not acceptable clinical relevance
• Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
• Gastrointestinal tract surgery that might affect absorption and elimination of drugs
• Diseases of the central nerve system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
• Chronic or relevant acute infections (e.g. HIV, hepatitis)
• History of allergy/hypersensitivity (including allergy to drug or its excipients) that are deemed relevant to subject's safety or the trial by the investigator
• Intake of drugs with a long half-life (\> 24 hours) within one month prior to administration of the trial drug except for allowed co-medication
• Treatment with glitazones, GLP-1 analogues, insulin, DPP-4 inhibitors, systemic or inhaled glucocorticoids, or anti-obesity drugs (e.g. orlistat) within 12 weeks prior to informed consent
• Sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin, verapamil, budesonide, buspirone, eplerenone , eletriptan, felodipine, fluticasone, midazolam, saquinavir, sildenafil, vardenafil) or CYP3A4 substrates with narrow therapeutic range (e.g. cyclosporine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) or drugs that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to first administration of the trial drug

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1283.2.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

6-(2-hydroxy-2-methylpropyl)-3-(1-(4-(1-methyl-2-oxo-1,2-dihydropyridin-4-yl)phenyl)ethyl)-6-phenyl-1,3-oxazinan-2-one

Condition Hierarchy (Ancestors)

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

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

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: January 24, 2011
• First Posted: January 25, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2011
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

DE (1)