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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01050127

Run by

Abbott

People needed

36

Starts

2009-12-01

Last updated by the study team

2010-11-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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%.

Where it is running

• Site Reference ID/Investigator# 24849 — Waukegan, Illinois, United States

Full record on ClinicalTrials.gov

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