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OpenTrials
Completed

NCT Number: NCT02189733

Bioequivalence 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caplacizumab

Biological

Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab

Primary outcomes

  1. Pharmacokinetics: concentration of caplacizumab in plasma

    Time frame: Day 1 (pre-dose) until Day 7

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ablynx, a Sanofi company

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2014
First posted
Jul 15, 2014
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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