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Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled BVD-523 in Volunteers

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ClinicalTrials.gov Identifier: NCT02994732
Recruitment Status : Completed
First Posted : December 16, 2016
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Drug: [14C]-BVD-523
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental [14C] - BVD-523 600mg Single Dose
Hide Arm/Group Description Subjects received a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that followed breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Period Title: Overall Study
Started 6 [1]
Completed 6 [2]
Not Completed 0
[1]
All subjects entered clinic on January 11, 2017
[2]
All subjects were discharged from the clinic by Jan 24, 2017
Arm/Group Title Single Arm Study
Hide Arm/Group Description Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
39.0  (16.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  33.3%
White
4
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants
24.9  (2.38)
1.Primary Outcome
Title Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) Tmax
Hide Description Time to peak concentration (Tmax), PK blood samples were taken at the following time points 0 (predose), 30 min, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose.
Time Frame Collected over 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Median (Standard Deviation)
Unit of Measure: hr
2.57  (3.0)
2.Primary Outcome
Title Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) Cmax
Hide Description peak (maximum) concentration
Time Frame Collected over 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All 6 subjects enrolled
Arm/Group Title Single Arm Study
Hide Arm/Group Description:
Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng/ml
1110  (619)
3.Primary Outcome
Title Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) t1/2
Hide Description Elimination half-life
Time Frame Collected over 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hr
8.75  (3.57)
4.Primary Outcome
Title Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) AUC
Hide Description Area under Curve (AUC), 0-24 hr
Time Frame Collected over 15 dyas
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/ml
8480  (3600)
5.Primary Outcome
Title Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) CL/F
Hide Description Oral Clearance (CL/F)
Time Frame Collected over 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: L/hr
73  (35.1)
6.Primary Outcome
Title Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) V/F
Hide Description Apparent volume of distribution (V/F)
Time Frame Collected over 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: L
899  (463)
7.Primary Outcome
Title Excretion Rate of 14C-labeled BVD-523(Radioactivity in Feces)
Hide Description Percent of dose excreted in feces
Time Frame Collected over 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: %of radioactive dose of [14C-BVD523
82  (4.72)
8.Primary Outcome
Title Excretion Rate of 14C-labeled BVD-523(Radioactivity in Urine)
Hide Description Percent of dose excreted in urine
Time Frame Collected over 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: % of radioactive dose of [14C-BVD523
14.8  (4.79)
9.Primary Outcome
Title Cumulative Whole Blood: Plasma Ratio Calculated for AUC0-12
Hide Description AUC from time zero to the 12 hr time point with concentration above the lower limit of quantitation
Time Frame Collected in 12 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/ml
0.464  (0.0354)
10.Primary Outcome
Title Cumulative Whole Blood: Plasma Ratio Calculated for AUC 0-24
Hide Description AUC from time zero to 24 hrs
Time Frame Collected in 24 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Experimental [14C] -BVD-523 600mg Single Dose
Hide Arm/Group Description:
Subjects will receive a single oral 600-mg (4 ×150-mg capsules) dose of BVD-523 containing approximately 200 µCi of [14C] labeled BVD-523 following a 2-hour fast that follows breakfast. Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/ml
0.409  (0.0297)
11.Secondary Outcome
Title Treatment-related Adverse Events
Hide Description Any treatment-emergent adverse events related or likely related to study treatment
Time Frame 27 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Single Arm Study
Hide Arm/Group Description:
Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
Time Frame 27 days
Adverse Event Reporting Description Adverse event definitions; assignment of severity, causality, action taken, and outcome; and procedures for reporting serious AEs (SAEs) are detailed in Appendix C of the protocol. None of the definitions differ from the clinicaltrials.gov definitions.
 
Arm/Group Title Single Arm Study
Hide Arm/Group Description Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American.
All-Cause Mortality
Single Arm Study
Affected / at Risk (%)
Total   0/6 (0.00%)    
Hide Serious Adverse Events
Single Arm Study
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm Study
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Gastrointestinal disorders   
Diarrhoea   1/6 (16.67%)  1
General disorders   
Fatigue   1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director of Translational Sciences
Organization: Biomed Valley Discoveries
Phone: 636-887-6429
EMail: Dknoerzer@biomed-valley.com
Layout table for additonal information
Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT02994732    
Other Study ID Numbers: 523HV001
First Submitted: November 14, 2016
First Posted: December 16, 2016
Results First Submitted: April 24, 2018
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019