Investigation of AV411 in Healthy Subjects

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Center Trial to Assess the Safety, Tolerability, and Pharmacokinetics of AV411 in Healthy Subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000410550

Enrollment

Registered

2006-09-19

Start date

2006-10-05

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

Single dose oral AV411 (30 mg) on Study day 1 Oral AV411 (30 mg) twice daily for 14 days beginning on Study day 3

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Nonsmoking.-No clinical abnormality in laboratory and urine analyses.-Normal renal function Glomerular Filtration Rate (GFR) >90 mL/min.-Liver enzymes less than twice the upper limit of normal.-Electrocardiogram within normal limits at screening.-Willing to use barrier contraceptive during the period of the study.-Negative pregnancy test on Study Day 1 for female subjects of child-bearing potential.

Exclusion criteria

Known hypersensitivity to Pinatos or its components.-Conditions which might affect drug absorption, metabolism or excretion.-Untreated mental illness, current drug addiction or abuse or alcoholism.-Donated blood in the past 90 days or have poor peripheral venous access.-Platelets <100,000 per mm3 or a history of thrombocytopenia.-Confirmed diagnosis of chronic liver disease.-Positive for HIV.-Female subjects who are pregnant or nursing mothers.

Outcome results