Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-01

Study Completion Date

2012-10-08

Brief Summary

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This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.

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Detailed Description

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Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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50 mg of AVL-292 and Placebo

50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition

Group Type EXPERIMENTAL

50 mg AVL-292

Intervention Type DRUG

Placebo capsules

Intervention Type DRUG

100 mg of AVL-292 and Placebo

100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition

Group Type EXPERIMENTAL

100 mg AVL-292

Intervention Type DRUG

Placebo capsules

Intervention Type DRUG

200 mg AVL-292

8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition

Group Type EXPERIMENTAL

200 mg AVL-292

Intervention Type DRUG

350 mg of AVL-292

350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition

Group Type EXPERIMENTAL

350 mg AVL-292

Intervention Type DRUG

Placebo - 8 capsules

8 placebo capsules once daily for 7 days administered orally under fasted condition

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DRUG

Placebo - 14 capsules

14 placebo capsules once daily for 7 days administered orally under fasted condition

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DRUG

Interventions

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50 mg AVL-292

Intervention Type DRUG

100 mg AVL-292

Intervention Type DRUG

200 mg AVL-292

Intervention Type DRUG

350 mg AVL-292

Intervention Type DRUG

Placebo capsules

Intervention Type DRUG

Other Intervention Names

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AVL-292 AVL-292 AVL-292 AVL-292

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33

Exclusion Criteria

* Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, ophthalmological, allergic or other major disorders;
* Use of any prescribed systemic or topical medication within 30 days of the first dose;
* Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first dose administration;
* Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes