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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Alteplase (from modified manufacturing process); Drug: Alteplase (from current manufacturing process); Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04419493

2019-004932-40 (EudraCT Number)

0135-0340

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

Part B: Alteplase, TPA-02 then Alteplase, TPA-05

Experimental group

Treatment:

Drug: Alteplase (from modified manufacturing process)

Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

Part B: Alteplase, TPA-05 then Alteplase, TPA-02

Active Comparator group

Treatment:

Drug: Alteplase (from current manufacturing process)

Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

Part A: Alteplase, TPA-05 then Alteplase, TPA-02

Experimental group

Description:

Open-label

Treatment:

Drug: Alteplase (from modified manufacturing process)

Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

Part A: Alteplase, TPA-02 then Alteplase, TPA-05

Active Comparator group

Treatment:

Drug: Alteplase (from current manufacturing process)

Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)