Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01290042
First received: January 27, 2011
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.


Condition Intervention Phase
Ulcerative Colitis
Crohn's Disease
Drug: AMG 181
Other: Placebo for AMG 181
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. [ Time Frame: 40 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To measure the area under the plasma concentration curve versus time of drug AMG 181. [ Time Frame: 29 Weeks ] [ Designated as safety issue: No ]
  • To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181. [ Time Frame: 29 Weeks ] [ Designated as safety issue: Yes ]
  • To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181. [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: February 2011
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Other: Placebo for AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Active Comparator: Active arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Drug: AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 18 and 34 kg/m2
  • Normal physical and neurological examination, clinical laboratory values and ECG
  • Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subjects with ulcerative colitis)
  • Crohn's Disease Activity Index (CDAI) score of >150 and < 450 at screening (for subjects with Crohn's disease)
  • Additional inclusion criteria apply

Exclusion Criteria:

  • History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion
  • History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years
  • Underlying condition(s) that predisposes the subject to infections
  • Disease limited to the rectum, i.e. within 10 cm of the anal verge (for subjects with ulcerative colitis)
  • Evidence of severe disease (as evidenced by an Hb concentration less or equal to 10g/dL; toxic megacolon, or an UCDAI score greater than 10) (for subjects with ulcerative colitis)
  • Subject has short bowel syndrome (for subjects with Crohn's disease)
  • Presence of an ostomy (for subjects with Crohn's disease)
  • Presence of a fistula (for subjects with Crohn's disease)
  • Additional exclusion criteria apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290042

Locations
United States, California
Research Site
Glendale, California, United States, 91206
United States, Connecticut
Research Site
Bridgeport, Connecticut, United States, 06606
Research Site
Danbury, Connecticut, United States, 06810
United States, Florida
Research Site
Miami, Florida, United States, 33143
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Australia, Queensland
Research Site
Herston, Queensland, Australia, 4006
Australia, South Australia
Research Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Research Site
Prahran, Victoria, Australia, 3004
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01290042     History of Changes
Other Study ID Numbers: 20101261
Study First Received: January 27, 2011
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014