Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01164904
First received: July 1, 2010
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)


Condition Intervention Phase
Ulcerative Colitis
Drug: Amg 181
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC) [ Time Frame: Through study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181 [ Time Frame: Through study completion ] [ Designated as safety issue: No ]
  • To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations [ Time Frame: Through study completion ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: July 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Ten escalating dose levels of AMG 181 administered as a single dose SC or IV in healthy volunteers and SC in subjects with mild-to-moderate ulcerative colitis.
Drug: Amg 181
Ten escalating dose levels of AMG 181 administered as single dose SC or IV, in healthy volunteers and SC subjects with mild-to-moderate ulcerative colitis.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Healthy Volunteers

  • Healthy male or female subjects of non-reproductive potential between 18 to 45 year-of -age
  • Body Mass Index (BMI) between 18 and 34 kg/m2
  • Normal physical and neurological examination, clinical laboratory values and ECG
  • Additional inclusion criteria apply

Inclusion Criteria: Subjects with Mild to Moderate Ulcerative Colitis

  • Male or female subjects between 18 to 55 year-of -age
  • Body Mass Index (BMI) between 18 and 34 kg/m2
  • Diagnosis of Ulcerative Colitis for at least 2 months
  • Active, mild to moderate disease as defined by an Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 9 (inclusive), with a minimum sigmoidoscopy score of 1
  • Additional inclusion criteria apply

Exclusion criteria: Healthy Volunteers

  • 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
  • Recent or on-going infection(s)
  • Underlying condition(s) that predisposes the subject to infections
  • Additional exclusion criteria apply

Exclusion criteria: Subjects with Mild to Moderate Ulcerative Colitis

  • Disease limited to the rectum, i.e. within 20 cm of the anal verge
  • Any prior gastrointestinal surgery
  • Evidence of severe disease (as evidenced by an Hb concentration <11g/dL; toxic megacolon, or an UCDAI score≥10)
  • Immunosuppressive therapy with either azathioprine, methotrexate, or mercaptopurine, within the past 3 months
  • Prior exposure to a biologic agent or cyclosporine A
  • Use of antibiotics within the past 2 weeks of screening and during screening period
  • Use of topical (e.g. suppository or enema) mesalamine or steroids within two weeks prior to day 1
  • 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: NCT01164904

Locations
United States, California
Research Site
Glendale, California, United States, 91206
United States, Connecticut
Research Site
Danbury, Connecticut, United States, 06810
United States, Minnesota
Research Site
Plymouth, Minnesota, United States, 55446
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
Australia, Western Australia
Research Site
Nedlands, Western Australia, Australia, 6009
New Zealand
Research Site
Auckland, New Zealand, 1023
Research Site
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01164904     History of Changes
Other Study ID Numbers: 20090107
Study First Received: July 1, 2010
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Inflammatory Bowel Disease
Amgen

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

ClinicalTrials.gov processed this record on August 26, 2014