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

NCT ID: NCT02061358

Last Updated: 2024-03-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Viral Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 - 3 mg UV-4B

Subjects receiving UV-4B 3 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 3 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Cohort 2 - 10 mg UV-4B

Subjects receiving UV-4B 10 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 10 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Cohort 3- 30 mg UV-4B

Subjects receiving UV-4B 30 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 30 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Cohort 4 - 90 mg UV-4B

Subjects receiving UV-4B 90 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 90 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Cohort 5 - 180 mg UV-4B

Subjects receiving UV-4B 180 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 180 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Cohort 6 - 360 mg UV-4B

Subjects receiving UV-4B 360 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 360 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Cohort 7 - 720 mg UV-4B

Subjects receiving UV-4B 720 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 720 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Cohort 8 - 1000 mg UV-4B

Subjects receiving UV-4B 1000 mg oral solution or placebo

Group Type EXPERIMENTAL

UV-4B 1000 mg

Intervention Type DRUG

Oral solution, single dose

Placebo

Intervention Type DRUG

Oral solution, single dose

Interventions

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UV-4B 3 mg

Oral solution, single dose

Intervention Type DRUG

UV-4B 10 mg

Oral solution, single dose

Intervention Type DRUG

UV-4B 30 mg

Oral solution, single dose

Intervention Type DRUG

UV-4B 90 mg

Oral solution, single dose

Intervention Type DRUG

UV-4B 180 mg

Oral solution, single dose

Intervention Type DRUG

UV-4B 360 mg

Oral solution, single dose

Intervention Type DRUG

UV-4B 720 mg

Oral solution, single dose

Intervention Type DRUG

UV-4B 1000 mg

Oral solution, single dose

Intervention Type DRUG

Placebo

Oral solution, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period
* Men: using barrier contraception measures during the study period

Exclusion Criteria

* Health conditions
* Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

Unither Virology

INDUSTRY

Sponsor Role collaborator

Emergent BioSolutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Murtaugh, Dr

Role: PRINCIPAL_INVESTIGATOR

Senior Medical Research Director, Quintiles

Locations

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Quintiles, Inc

Overland Park, Kansas, United States

Site Status

Countries

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United States

References

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Callahan M, Treston AM, Lin G, Smith M, Kaufman B, Khaliq M, Evans DeWald L, Spurgers K, Warfield KL, Lowe P, Duchars M, Sampath A, Ramstedt U. Randomized single oral dose phase 1 study of safety, tolerability, and pharmacokinetics of Iminosugar UV-4 Hydrochloride (UV-4B) in healthy subjects. PLoS Negl Trop Dis. 2022 Aug 8;16(8):e0010636. doi: 10.1371/journal.pntd.0010636. eCollection 2022 Aug.

Reference Type DERIVED
PMID: 35939501 (View on PubMed)

Related Links

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http://www.niaid.nih.gov/topics/denguefever/Pages/default.aspx

Information on dengue fever

Other Identifiers

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KQA71264

Identifier Type: -

Identifier Source: secondary_id

UV-DEN-0001

Identifier Type: -

Identifier Source: secondary_id

DMID 13-0001

Identifier Type: -

Identifier Source: org_study_id

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