Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Unither Virology
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Unither Virology
ClinicalTrials.gov Identifier:
NCT02061358
First received: February 6, 2014
Last updated: January 29, 2015
Last verified: January 2015
  Purpose

The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.


Condition Intervention Phase
Dengue Fever
Drug: UV-4B, 3 mg to 1000 mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single-Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Unither Virology:

Primary Outcome Measures:
  • Evaluation and occurrence of AEs and serious AEs (SAEs) [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
  • Determination of changes from baseline for vital signs, ECGs, and clinical laboratory tests [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure of UV-4 plasma and urine concentrations and PK parameters [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: July 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cohort 1, groups (a) and (b)
Group a: 1:1; UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose
Placebo Comparator: Cohort 2, groups (a) and (b)
Group a: 1:1; UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose
Placebo Comparator: Cohort 3, groups (a) and (b)
Group a: 1:1, UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose
Placebo Comparator: Cohort 4, groups (a) and (b)
Group a: 1:1; UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose
Placebo Comparator: Cohort 5, groups (a) and (b)
Group a: 1:1; UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose
Placebo Comparator: Cohort 6, groups (a) and (b)
Group a: 1:1, UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose
Placebo Comparator: Cohort 7, groups (a) and (b)
Group a: 1:1; UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose
Placebo Comparator: Cohort 8, groups (a) and (b)
Group a: 1:1, UV-4B:Placebo, Group b: 5:1 UV-4B:Placebo
Drug: UV-4B, 3 mg to 1000 mg
Oral solution, single dose
Drug: Placebo
Oral solution, single dose

Detailed Description:

The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus genus. There are four DENV serotypes. Infection with one serotype results in lifelong immunity against that serotype, but only limited short-term cross-protection from infection with the other serotypes. Immunity to one serotype has a downside as subsequent infections by other serotypes increase the risk of developing more severe forms of dengue, which includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV infections per year distributed over 100 countries. Recent cartographic-based modeling studies suggest that up to 390 million of dengue infections per year, of which 96 million are associated with clinical symptoms.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Subjects
  • Non-child bearing potential

Exclusion Criteria:

  • Health conditions
  • Taking other prescription and non-prescription dugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061358

Contacts
Contact: Denise Kelly 913-708-6480 denise.kelly@quintiles.com
Contact: Marla Woodfolk, BS 202-350-4523 mwoodfolk@unithervirology.com

Locations
United States, Kansas
Quintiles, Inc Recruiting
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Unither Virology
Quintiles
Investigators
Principal Investigator: Thomas Murtaugh, Dr Senior Medical Research Director, Quintiles
  More Information

No publications provided

Responsible Party: Unither Virology
ClinicalTrials.gov Identifier: NCT02061358     History of Changes
Other Study ID Numbers: DMID 13-0001, KQA71264, UV-DEN-0001
Study First Received: February 6, 2014
Last Updated: January 29, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015