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

A Phase 1, Two-part Study to Investigate the Safety and Pharmacokinetics of AVL-292 Following Multiple Oral Doses and to Evaluate the Effect of Food on the Pharmacokinetics of AVL-292 Following a Single Oral Dose in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01692184

Enrollment

Registered

2012-09-25

Start date

2012-08-01

Completion date

2012-10-08

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AVL-292, Safety, Pharmacokinetics, Pharmacodynamics, Pharmacology, Clinical

Brief summary

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.

Detailed description

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.

Interventions

DRUG50 mg AVL-292

DRUG100 mg AVL-292

DRUG200 mg AVL-292

DRUG350 mg AVL-292

DRUGPlacebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	Up to 28 days after last AVL-292 dose	Number of participants with adverse events
PK-(Cmax)	24 hours after the last AVL-292 dose on days 1 and 7	Maximum observed concentration in plasma
PK-(AUC)	24 hours after the last AVL-292 dose days 1 and 7	Area under the plasma concentration-time curve

Secondary

Measure	Time frame	Description
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells	24 hours after the last AVL-292 dose days 1 and 7	Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026