Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189733
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Ablynx

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.

The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Caplacizumab Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
Study Start Date : July 2014
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Caplacizumab - Treatment A
Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab
 Biological: Caplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
Experimental: Caplacizumab - Treatment B
Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab
 Biological: Caplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pharmacokinetics: concentration of caplacizumab in plasma [ Time Frame: Day 1 (pre-dose) until Day 7 ]

Secondary Outcome Measures :
  1. Pharmacodynamics as measured by Ristocetin cofactor activity in plasma [ Time Frame: During screening until day 29 +/-1 ]
  2. Safety and Tolerability: safety markers [ Time Frame: From signing of informed consent form until day 43 +/- 2 ]
    Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations

  3. Pharmacodynamics as measured by von Willebrand factor antigen in plasma [ Time Frame: During screening until Day 29 +/- 1 ]
  4. Pharmacodynamics as measured by Factor VIII clotting activity in plasma [ Time Frame: During screening until day 29 +/- 1 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male Caucasians aged 18 to 55 years, inclusive.
  • Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.
  • Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -1.
  • Others as defined in the protocol.

Exclusion Criteria:

  • History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
  • Others as defined in the protocol
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189733


Locations
Layout table for location information
United Kingdom
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Ablynx
Investigators
Layout table for investigator information
Study Director: Jean-Michel Paillarse, MD Ablynx
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02189733    
Other Study ID Numbers: ALX0681-C102
2014-001294-13 ( EudraCT Number )
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: July 2014