MedPath

A Study in Healthy Men to Compare 2 Different Formulations of Alteplase

Phase 1
Completed
Conditions
Healthy
Interventions
Registration Number
NCT04419493
Lead Sponsor
Boehringer Ingelheim
Brief Summary

To establish the bioequivalence of alteplase derived from two different manufacturing processes.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
30
Inclusion Criteria
  • Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 45 years (inclusive)
  • Body mass index (weight divided by height squared) (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Body weight of 65 - 100 kg (inclusive) at screening
  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
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Exclusion Criteria
  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, e.g. thrombotic predisposition according to thrombophilic testing
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity
  • During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection Further exclusion criteria apply.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Part B: Alteplase, TPA-02 then Alteplase, TPA-05Heparin-Natrium-5000-ratiopharm (unfractionated heparin)-
Part B: Alteplase, TPA-05 then Alteplase, TPA-02Alteplase (from current manufacturing process)-
Part B: Alteplase, TPA-05 then Alteplase, TPA-02Heparin-Natrium-5000-ratiopharm (unfractionated heparin)-
Part A: Alteplase, TPA-05 then Alteplase, TPA-02Alteplase (from modified manufacturing process)Open-label
Part A: Alteplase, TPA-05 then Alteplase, TPA-02Heparin-Natrium-5000-ratiopharm (unfractionated heparin)Open-label
Part A: Alteplase, TPA-02 then Alteplase, TPA-05Heparin-Natrium-5000-ratiopharm (unfractionated heparin)-
Part B: Alteplase, TPA-02 then Alteplase, TPA-05Alteplase (from modified manufacturing process)-
Part A: Alteplase, TPA-02 then Alteplase, TPA-05Alteplase (from current manufacturing process)-
Primary Outcome Measures
NameTimeMethod
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

The area under the concentration-time curve of Alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax)Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

Maximum measured concentration of Alteplase in plasma (Cmax) is reported.

Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

The area under the concentration-time curve of alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

Part A: Maximum Measured Concentration of Alteplase in Plasma (Cmax)Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

Maximum measured concentration of alteplase in plasma is reported.

Secondary Outcome Measures
NameTimeMethod
Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

Area under the concentration-time curve of alteplase in plasma over interval from 0 extrapolated to infinity is reported.

Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞)Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

Area under the concentration-time curve of alteplase in plasma over the interval from 0 extrapolated to infinity is reported.

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach

🇩🇪

Biberach, Germany

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