Phase 1 Safety and Pharmacokinetics Study of Single Ascen... | NCT02558413

Studies
Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers

NCT02558413

Sponsor

Biota Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

60Actual

Phase

Phase 1

Conditions

Pharmacokinetics
Healthy Volunteers

Interventions

BTA-C585 oral capsules
BTA-C585 matching placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 22, 2015

First Submission Date that Met QC Criteria

Sep 23, 2015

First Posted Date

Sep 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2018

Last Update Posted Date

May 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BTA-C585 oral capsules	Active Comparator	25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 mg	Drug: BTA-C585 oral capsules
BTA-C585 matching placebo	Placebo Comparator	BTA-C585 Matching placebo capsules; single doses	Drug: BTA-C585 matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BTA-C585 oral capsules	Drug	BTA-C585; Single ascending doses from 50 mg to 800 mg	BTA-C585 oral capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse events		Day 0 to Day 11
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours		0-24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men and women aged 18-60 years;
Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32;
Female subjects must be of non-childbearing potential;
Male subjects must agree to use a double barrier method of birth control;
Able to provide informed consent

Exclusion Criteria:

Current or recent (within 14 days of Day 0) bacterial or viral infection;
Positive results for hepatitis B, hepatitis C, or HIV;
Clinically significant abnormalities noted on ECG;
Safety laboratory abnormalities;
Regular use of medications, prescription or non-prescription;
Poor vein access or fear of venipuncture;
Major surgery, significant recent injury or trauma within 30 days;
Received an investigational drug or vaccine within 30 days

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Novotney-Barry	Biota Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biota Investigational Site		San Antonio	Texas	78209	United States

Condition Browse Module

MeSH Terms

ID	Term
D014777	Virus Diseases
D018184	Paramyxoviridae Infections

Ancestor Terms

ID	Term
D007239	Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided