NCT00959634

Brief Summary

This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

November 3, 2010

Status Verified

September 1, 2010

Enrollment Period

1 month

First QC Date

August 12, 2009

Last Update Submit

November 2, 2010

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)

    One day before dosing through day of last dose and up to 6 days after last dose

  • ABT-126 levels in blood (plasma)

    First dose through last dose and up to 192 hours after last dose

Study Arms (3)

1

EXPERIMENTAL

Dose 1 BID

Drug: ABT-126

2

EXPERIMENTAL

Dose 2 BID

Drug: ABT-126

3

PLACEBO COMPARATOR

Placebo BID

Drug: Placebo

Interventions

ABT-126DRUG

Dose administered twice daily on Study Days 1-10

12
PlaceboDRUG

Dose administered twice daily on Study Days 1-10

3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects between 18 and 50 years of age
  • If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
  • If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration

You may not qualify if:

  • Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis
  • History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder
  • Presence of any uncontrolled medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 22863

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

ABT-126

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 14, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2009

Last Updated

November 3, 2010

Record last verified: 2010-09

Locations

US(1)