NCT01692184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2012

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

September 21, 2012

Last Update Submit

October 31, 2019

Conditions

Healthy

Keywords

AVL-292SafetyPharmacokineticsPharmacodynamicsPharmacology, Clinical

Outcome Measures

Primary Outcomes (3)

  • Adverse Events

    Number of participants with adverse events

    Up to 28 days after last AVL-292 dose

  • PK-(Cmax)

    Maximum observed concentration in plasma

    24 hours after the last AVL-292 dose on days 1 and 7

  • PK-(AUC)

    Area under the plasma concentration-time curve

    24 hours after the last AVL-292 dose days 1 and 7

Secondary Outcomes (1)

  • 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

Study Arms (6)

50 mg of AVL-292 and Placebo

EXPERIMENTAL

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

Drug: 50 mg AVL-292Drug: Placebo capsules

100 mg of AVL-292 and Placebo

EXPERIMENTAL

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

Drug: 100 mg AVL-292Drug: Placebo capsules

200 mg AVL-292

EXPERIMENTAL

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

Drug: 200 mg AVL-292

350 mg of AVL-292

EXPERIMENTAL

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

Drug: 350 mg AVL-292

Placebo - 8 capsules

PLACEBO COMPARATOR

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

Drug: Placebo capsules

Placebo - 14 capsules

PLACEBO COMPARATOR

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

Drug: Placebo capsules

Interventions

50 mg AVL-292DRUG
Also known as: AVL-292
50 mg of AVL-292 and Placebo
100 mg AVL-292DRUG
Also known as: AVL-292
100 mg of AVL-292 and Placebo
200 mg AVL-292DRUG
Also known as: AVL-292
200 mg AVL-292
350 mg AVL-292DRUG
Also known as: AVL-292
350 mg of AVL-292
Placebo capsulesDRUG
100 mg of AVL-292 and Placebo50 mg of AVL-292 and PlaceboPlacebo - 14 capsulesPlacebo - 8 capsules

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Study Officials

  • Maria Palmisano, MD

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 25, 2012

Study Start

August 1, 2012

Primary Completion

October 8, 2012

Study Completion

October 8, 2012

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

US(1)