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

NCT01050127 | Completed Phase 1

• 1 other identifier: M11-731
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Pharmacokinetics; Pharmacodynamics; Drug Safety; Phase 1 Clinical Trial

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)

  Days -2 through Day 7 or 14

• Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)

  Day -1 through Day 7

• Pharmacodynamics (i.e., biomarkers of drug effect)

  Day -1 through Day 7

Study Arms (3)

Low dose ABT-436

EXPERIMENTAL

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

Drug: ABT-436; Drug: Placebo

Mid Dose ABT-436

EXPERIMENTAL

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

Drug: ABT-436; Drug: Placebo

High Dose ABT-436

EXPERIMENTAL

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

Drug: ABT-436; Drug: Placebo

Interventions

ABT-436 DRUG

See Arm Description for details.

High Dose ABT-436; Low dose ABT-436; Mid Dose ABT-436

Placebo DRUG

See Arm Description for details.

High Dose ABT-436; Low dose ABT-436; Mid Dose ABT-436

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age is between 18 and 55 years, inclusive.
• If female, subject must be postmenopausal for at least two years or surgically sterile.
• Females must have negative results for pregnancy tests prior to study drug administration.
• If male, subject must be surgically sterile or agree to be sexually inactive or agree to use a barrier method of birth control.
• Body Mass Index is 18.0 to 29.9 kg/m2 (2 = superscript number), inclusive.
• 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.
• 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.

You may not qualify if:

• History of significant sensitivity or allergy to any drug.
• 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.
• 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.
• Receipt of any depot drug by injection within 30 days prior to study drug administration.
• Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.
• Use of tobacco or other nicotine-containing products within the six-month period preceding study drug administration.
• 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.
• 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.
• 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).
• HbA1c \> 6.0%.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 24849

Waukegan, Illinois, 60085, United States

Location

Study Design

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

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: January 15, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Last Updated: November 3, 2010

Record last verified: 2010-09

Locations

US (1)