Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

Healthy Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189733
• Other study ID #: ALX0681-C102
• Secondary ID: 2014-001294-13
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2014
• Last updated: November 13, 2014
• Start date: July 2014

Study information

• Verified date: July 2014
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• Caplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: concentration of caplacizumab in plasma		Day 1 (pre-dose) until Day 7	No
Secondary	Pharmacodynamics as measured by Ristocetin cofactor activity in plasma		During screening until day 29 +/-1	No
Secondary	Safety and Tolerability: safety markers	Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations	From signing of informed consent form until day 43 +/- 2	Yes
Secondary	Pharmacodynamics as measured by von Willebrand factor antigen in plasma		During screening until Day 29 +/- 1	No
Secondary	Pharmacodynamics as measured by Factor VIII clotting activity in plasma		During screening until day 29 +/- 1	No