Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262794
• Other study ID #: RA0074
• Secondary ID: 2010-022543-38
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2010
• Last updated: September 26, 2011
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.

To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese volunteers

Exclusion Criteria:

• Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.

• Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• CDP6038
100 mg/mL solution for injection, single dose
• Placebo
0.9% sodium chloride for injection Single-dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum drug concentration (Cmax)		Multiple sampling from 0 to 113 days following single dose	No
Primary	Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)		Multiple sampling from 0 to 113 days following single dose	No
Primary	Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)		Multiple sampling from 0 to 113 days following single dose	No
Primary	Apparent volume of distribution (Vz/F)		Multiple sampling from 0 to 113 days following single dose	No
Primary	Apparent total body clearance (CL/F)		Multiple sampling from 0 to 113 days following single dose	No
Primary	Terminal elimination half-life (T½)		Multiple sampling from 0 to 113 days following single dose	No
Secondary	PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects		Multiple sampling from 0 to 15 weeks following single dose	No
Secondary	Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects		Multiple sampling from 0 to 15 weeks following single dose	No