First-in-Human, Single Ascending Oral Dose Study of DV-928 in Healthy Volunteers

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of DV-928 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001022651

Acronym

Nil

Enrollment

Registered

2014-09-24

Start date

2014-10-16

Completion date

2015-02-04

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

This research project is being conducted to look at how safe and well tolerated a new drug called DV-928 is when different amounts are given to healthy volunteers. The pharmacokinetics of DV-928 will also be studied; this is done by measuring the amount of DV-928 in the blood at different times throughout the initial 2 days following administration, allowing us to evaluate how DV-928 is handled by the body (for example how quickly it gets into the blood stream).

Interventions

DV-928 powder for reconstitution and oral administration. Each subject will receive a single dose of either active DV-928 or placebo (calcium carbonate) according to the Cohort they are participating in and the intervention they are randomised to. 1. The doses of the intervention are described below per cohort: * Cohort 1: DV-928 or placebo (30 mg) * Cohort 2: DV-928 or placebo (100 mg) * Cohort 3: DV-928 or placebo (300 mg) * Cohort 4: DV-928 or placebo (600 mg) * Cohort 5: DV-928 or placebo (

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

- Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening; - Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed. - Female subjects must be of non-childbearing potential

Exclusion criteria

- Significant blood loss or donated blood in the 30 days prior to study participation - Participation in an investigational drug study within 30 days prior to dosing. - History of drug or alcohol abuse. - Use of any medications, including OTC and herbal or nutritional supplements during the week prior to drug dosing - Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test. - Clinically significant abnormalities

Outcome results