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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262794
First Posted: December 17, 2010
Last Update Posted: September 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  Purpose

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


Condition Intervention Phase
Healthy Volunteers Biological: CDP6038 Biological: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Maximum drug concentration (Cmax) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ]
  • Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ]
  • Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ]
  • Apparent total body clearance (CL/F) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ]
  • Terminal elimination half-life (T½) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Multiple sampling from 0 to 15 weeks following single dose ]
  • Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects [ Time Frame: Multiple sampling from 0 to 15 weeks following single dose ]

Enrollment: 20
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP6038 0.3 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Experimental: CDP6038 1 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Experimental: CDP6038 3 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Experimental: CDP6038 6 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Placebo Comparator: Placebo Biological: Placebo
0.9% sodium chloride for injection Single-dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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): NCT01262794


Locations
United Kingdom
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01262794     History of Changes
Other Study ID Numbers: RA0074
2010-022543-38 ( EudraCT Number )
First Submitted: December 16, 2010
First Posted: December 17, 2010
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by UCB Pharma:
Healthy volunteers
Japanese