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

Phase 1

Completed

• Conditions: Treatment of Fatty Liver Disease; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12614001022651
• Lead Sponsor: INC Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1:<br>To evaluate the safety and tolerability of single, ascending oral doses of DV-928 in healthy volunteers.<br><br>[Timepoint for Primary Outcome 1: Various safety measures including safety laboratory tests, 12-lead ECGs and Adverse Events collected at various timepoints in the 48 hours post study drug administration and during the 7-day follow up visit. <br><br>];Primary Outcome 2:<br>To characterize the pharmacokinetics of DV-928 in plasma following administration of single, ascending oral doses in healthy volunteers<br>[Timepoint for Primary Outcome 2: PK samples at pre-dose (pre-dose, representing baseline concentration levels) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.]

Secondary Outcome Measures

Name	Time	Method
To determine any dose limiting adverse drug effects following single ascending oral dosing of DV-928 in healthy volunteers.<br><br>Routine vital sign measurements (blood pressure [BP], pulse and respiratory rate [RR]) will be measured at various timepoints from screening until trial completion. <br>Physical examinations will be performed at screening, Day -1, and at trial completion. <br>Safety Laboratory tests (Chemistry, Hematology, Gamma-glutamyl transpeptidase (GGT), and Urinalysis) will be drawn at various timepoints from screening until trial completion. <br>Twelve-lead ECGs will be obtained from subjects at various timepoints from screening until 48 hours post dose and additional ECGs may be obtained if clinically indicated.<br>[Timepoint: Adverse events will be reported following study drug administration throughout the 7 day duration of each cohort, for all cohorts.<br><br>]