NCT01695876

Brief Summary

Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2012

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 4, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

September 26, 2012

Last Update Submit

March 2, 2015

Conditions

Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects.

    up to 35 days

Secondary Outcomes (2)

  • Pharmacodynamics

    up to 35 days

  • Effect of Food on AMG 357

    up to 11 days

Study Arms (2)

AMG 357

EXPERIMENTAL

AMG 357 is a small molecule for treatment of inflammatory disease

Drug: AMG 357

Placebo

PLACEBO COMPARATOR

Matching placebo to AMG 357 containing no active drug

Drug: Placebo

Interventions

AMG 357DRUG

Oral administration available in varying dose strength.

AMG 357
PlaceboDRUG

Matching placebo to AMG 357 containing no active drug

Placebo

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Adult subjects between 25 and 55 years old
  • Body mass index (BMI) between 18 and 32 kg/m2
  • Normal or clinically acceptable physical examination, clinical laboratory values, and ECG

You may not qualify if:

  • Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Christchurch, 8011, New Zealand

Location

Unknown Facility

Christchurch, New Zealand

Location

Research Site

Grafton, Auckland, 1010, New Zealand

Location

Related Links

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

March 4, 2015

Record last verified: 2015-01

Locations

NZ(3)