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

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ABT-436; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01050127

M11-731

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Low dose ABT-436

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABT-436

Mid Dose ABT-436

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABT-436

High Dose ABT-436

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABT-436