A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AD-6626 in Normal, Healthy Volunteers

A Single-Center, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of AD 6626 Administered Orally to Normal, Healthy Volunteers

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000601538

Enrollment

Registered

2015-06-09

Start date

2015-06-23

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

Brief summary

The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of multiple doses of oral AD-6626 in normal healthy volunteers

Interventions

The study consists of sequential dose escalation with approximately 3 cohorts of subjects (8 subjects per cohort) given oral doses of AD-6626 or placebo given twice daily for 10 days. The doses of AD-6626 are 150mg, 300mg, and 600mg. The AD-6626 is dissolved in cranberry juice for administration

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

21 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

This study will be conducted in normal, healthy, adult, male or female aged between 21-45 years and with a BMI greater than or equal to 18 and less than or equal to 30. Eligible subjects will be in good health without signs or symptoms of current illness and with predose clinical and laboratory examinations without clinically significant findings.

Exclusion criteria

- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases - History of severe allergic or anaphylactic reactions - Fever (body temperature >38 degrees celsius) or symptomatic viral or bacterial infection within 2 weeks prior to Screening - Blood pressure (BP) >140/90 mm Hg or a heart rate (HR) >100 beats per minute at Screening and at Day -1 - Clinically significant laboratory abnormalities - Female who is breastfeeding or has a positive pregnancy test at any visit

Outcome results