Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

November 13, 2014 updated by: Ablynx

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: concentration of caplacizumab in plasma
Time Frame: Day 1 (pre-dose) until Day 7
Day 1 (pre-dose) until Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamics as measured by Ristocetin cofactor activity in plasma
Time Frame: During screening until day 29 +/-1
During screening until day 29 +/-1
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
From signing of informed consent form until day 43 +/- 2
Pharmacodynamics as measured by von Willebrand factor antigen in plasma
Time Frame: During screening until Day 29 +/- 1
During screening until Day 29 +/- 1
Pharmacodynamics as measured by Factor VIII clotting activity in plasma
Time Frame: During screening until day 29 +/- 1
During screening until day 29 +/- 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ablynx

Investigators

  • Study Director: Jean-Michel Paillarse, MD, Ablynx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • ALX0681-C102
  • 2014-001294-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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