A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- ABT-436
- Conditions
- Healthy
- Sponsor
- Abbott
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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%.
Arms & Interventions
Low dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
Intervention: ABT-436
Low dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
Intervention: Placebo
Mid Dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
Intervention: ABT-436
Mid Dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
Intervention: Placebo
High Dose ABT-436
ABT-436 or placebo administered once daily for 14 days.
Intervention: ABT-436
High Dose ABT-436
ABT-436 or placebo administered once daily for 14 days.
Intervention: Placebo
Outcomes
Primary Outcomes
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)
Time Frame: Days -2 through Day 7 or 14
Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)
Time Frame: Day -1 through Day 7
Pharmacodynamics (i.e., biomarkers of drug effect)
Time Frame: Day -1 through Day 7