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Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

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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

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 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

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




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 ]


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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

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
United Kingdom
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Jean-Michel Paillarse, MD Ablynx

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02189733     History of Changes
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