Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban in Healthy Subjects

NCT02264119 | Completed Phase 1

• 1 other identifier: 509.119
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)

  Up to 168 hours after first drug administration

• Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)

  Up to 168 hours after first drug administration

• Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)

  Up to 168 hours after first drug administration

• Amount of the analyte eliminated unchanged in the urine per dosing interval (Ae% (i=1,...,13))

  Up to 168 hours after first drug administration

Secondary Outcomes (10)

• Pre-dose concentration lf the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))

  Up to 168 hours after first drug administration

• Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))

  up to 2 hours after each dosing interval

• Terminal half life of the analyte in plasma (t1/2)

  Up to 168 hours after first drug administration

• Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swing,i)

  Up to 168 hours after first drug administration

• Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)

  Up to 168 hours after first drug administration

Study Arms (4)

Lefradafiban tablet with Pantoprazole

EXPERIMENTAL

Drug: Lefradafiban tablet; Drug: Pantoprazole tablet

Lefradafiban tablet without Pantoprazole

ACTIVE COMPARATOR

Drug: Lefradafiban tablet

Lefradafiban double chamber sachet with Pantoprazole

EXPERIMENTAL

Drug: Pantoprazole tablet; Device: Lefradafiban double chamber sachet

Lefradafiban double chamber sachet without Pantoprazole

ACTIVE COMPARATOR

Device: Lefradafiban double chamber sachet

Interventions

Lefradafiban tablet DRUG

Lefradafiban tablet with Pantoprazole; Lefradafiban tablet without Pantoprazole

Pantoprazole tablet DRUG

Lefradafiban double chamber sachet with Pantoprazole; Lefradafiban tablet with Pantoprazole

Lefradafiban double chamber sachet DEVICE

Lefradafiban double chamber sachet with Pantoprazole; Lefradafiban double chamber sachet without Pantoprazole

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age ≥ 18 and ≤ 60 years, planned stratification: age \< 40 years (4 subjects) and ≥ 40 years (8 subjects)
• Broca ≥ - 20 % and ≤ + 20 %

You may not qualify if:

• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• Drug abuse
• Alcohol abuse (\> 60 g/day)
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Excessive physical activities within 5 days prior to administration or during the trial
• Blood donation within 1 month prior to administration or during the trial
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
• Chronic or relevant acute infections
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• History of
• Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Any bleeding disorder including prolonged or habitual bleeding
• Other hematologic disease

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

lefradafiban; Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 15, 2014
• Study Start: April 1, 1998
• Primary Completion: July 1, 1998
• Last Updated: October 15, 2014

Record last verified: 2014-10