Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
This study is currently recruiting participants.
Verified September 2012 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01258205
First received: December 9, 2010
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: AMG 139 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139 [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part B
One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.
|
Drug: AMG 139
Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).
|
|
Experimental: Part A
Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.
|
Drug: AMG 139
Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Part A - Healthy Subjects:
- Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
- Body mass index (BMI) between 18 and 32 kg/m2
- Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
- Additional inclusion criteria apply
Part B - Crohn's Subjects:
- Male or female subjects with CD between 18 to 55 years-of-age
- Body mass index (BMI) between 18 and 32 kg/m2
- Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of mild to severe CD
- Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months
- Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to or greater than 180 and equal to or less than 450
- Elevated fecal calprotectin and CRP
- Additional inclusion criteria apply
Exclusion Criteria:
Parts A - Healthy Subjects:
- 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 evaluation, procedures or completion;
- Recent or on-going infection(s)
- Underlying condition(s) that predisposes the subject to infections
- History of malignancy of any type
- Additional exclusion criteria apply
Part B only - Crohn's Subjects:
- 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 evaluation, procedures or completion;
- Recent or on-going infection(s)
- Underlying condition(s) that predisposes the subject to infections
- History of malignancy of any type
- Additional exclusion criteria apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258205
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Locations
| United States, New Jersey | |
| Research Site | Recruiting |
| Berlin, New Jersey, United States, 08009 | |
| United States, New York | |
| Research Site | Recruiting |
| Stony Brook, New York, United States, 11794-8174 | |
| United States, Oklahoma | |
| Research Site | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Virginia | |
| Research Site | Recruiting |
| Richmond, Virginia, United States, 23291 | |
| Australia, Queensland | |
| Research Site | Recruiting |
| Herston, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Research Site | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Research Site | Recruiting |
| Prahran, Victoria, Australia, 3181 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01258205 History of Changes |
| Other Study ID Numbers: | 20090519 |
| Study First Received: | December 9, 2010 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Western Institutional Review Board Australia: Human Research Ethics Committee United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Amgen AMG 139 Crohn's Disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013