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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04419493
Collaborator
(none)
30
1
3
11.9
2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Alteplase (from modified manufacturing process)
  • Drug: Alteplase (from current manufacturing process)
  • Drug: Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Part A: Open label Part B: Adaptive two-stage group-sequential designPart A: Open label Part B: Adaptive two-stage group-sequential design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers
Actual Study Start Date :
Jun 23, 2020
Actual Primary Completion Date :
Jun 21, 2021
Actual Study Completion Date :
Jun 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part B: Test treatment (T)

Drug: Alteplase (from modified manufacturing process)
Alteplase

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

Active Comparator: Part B: Reference treatment (R)

Drug: Alteplase (from current manufacturing process)
Alteplase

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

Experimental: Part A: Test

Open-label

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

Outcome Measures

Primary Outcome Measures

  1. AUC 0-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 6 hours]

  2. Cmax (maximum measured concentration of the analyte in plasma) [up to 6 hours]

Secondary Outcome Measures

  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 6 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humanpharmakologisches Zentrum Biberach Biberach Germany 88397

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04419493
Other Study ID Numbers:
  • 0135-0340
  • 2019-004932-40
First Posted:
Jun 5, 2020
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2021