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A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults

NCT ID: NCT01050127

Last Updated: 2010-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.

Detailed Description

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Conditions

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Healthy

Keywords

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Pharmacokinetics Pharmacodynamics Drug Safety Phase 1 Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose ABT-436

ABT-436 or placebo administered once daily for 7 days.

Group Type EXPERIMENTAL

ABT-436

Intervention Type DRUG

See Arm Description for details.

Placebo

Intervention Type DRUG

See Arm Description for details.

Mid Dose ABT-436

ABT-436 or placebo administered once daily for 7 days.

Group Type EXPERIMENTAL

ABT-436

Intervention Type DRUG

See Arm Description for details.

Placebo

Intervention Type DRUG

See Arm Description for details.

High Dose ABT-436

ABT-436 or placebo administered once daily for 14 days.

Group Type EXPERIMENTAL

ABT-436

Intervention Type DRUG

See Arm Description for details.

Placebo

Intervention Type DRUG

See Arm Description for details.

Interventions

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ABT-436

See Arm Description for details.

Intervention Type DRUG

Placebo

See Arm Description for details.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age is between 18 and 55 years, inclusive.
2. If female, subject must be postmenopausal for at least two years or surgically sterile.
3. Females must have negative results for pregnancy tests prior to study drug administration.
4. If male, subject must be surgically sterile or agree to be sexually inactive or agree to use a barrier method of birth control.
5. Body Mass Index is 18.0 to 29.9 kg/m2 (2 = superscript number), inclusive.
6. A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram.
7. Must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria

1. History of significant sensitivity or allergy to any drug.
2. Use of known inhibitors or inducers of CYP3A within 30 days prior to the first dose of study drug and through the end of the study.
3. Requirement for, or use of within the 2-week period prior to study drug administration, any over-the-counter or prescription medication, vitamins, minerals or herbal supplements on a regular basis.
4. Receipt of any depot drug by injection within 30 days prior to study drug administration.
5. Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.
6. Use of tobacco or other nicotine-containing products within the six-month period preceding study drug administration.
7. Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug.
8. Receipt of an investigational product within a time period equal to 10 half-lives, if known, or a minimum of 6 weeks prior to study drug administration.
9. Has a clinically significant abnormal diastolic blood pressure (\< 45 or \> 90 mm Hg), systolic blood pressure (\< 85 or \> 140 mm Hg) or heart rate (\< 45 or \> 100 bpm).
10. HbA1c \> 6.0%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Site Reference ID/Investigator# 24849

Waukegan, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M11-731

Identifier Type: -

Identifier Source: org_study_id