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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
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc

Brief Summary:

The primary objective of this study is to characterize the metabolic disposition, pharmacokinetics (PK), and routes of elimination of [14C]‑labeled BVD‑523 after administration of a single, oral dose to healthy male subjects.

The secondary objective of this study is to evaluate the safety and tolerability of a single oral dose of [14C]‑labeled BVD‑523 in healthy male subjects.


Condition or disease Intervention/treatment Phase
Healthy Drug: BVD-523 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BVD-523 Following Single Oral Dose Administration in Healthy Male Subjects
Actual Study Start Date : January 2017
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 15, 2017

Arm Intervention/treatment
Experimental: [14C]‑BVD‑523 600mg single dose
Open-label, nonrandomized, absorption, metabolism, and excretion study of [14C]‑BVD‑523 administered as a 600 mg (approximately 200 µCi) oral dose to 6 healthy male subjects following at least an 8‑hour fast from food (not including water).
Drug: BVD-523



Primary Outcome Measures :
  1. Pharmacokinetics of 14C-labeled BVD-523(radioactivity in whole blood and plasma) tmax [ Time Frame: Collected over 15 days ]
    Time to peak concentration (Tmax)

  2. Pharmacokinetics of 14C-labeled BVD-523(radioactivity in whole blood and plasma) Cmax [ Time Frame: Collected over 15 days ]
    peak (maximum) concentration

  3. Pharmacokinetics of 14C-labeled BVD-523(radioactivity in whole blood and plasma) t1/2 [ Time Frame: Collected over 15 days ]
    Elimination half-life

  4. Pharmacokinetics of 14C-labeled BVD-523(radioactivity in whole blood and plasma) AUC [ Time Frame: Collected over 15 dyas ]
    Area under Curve (AUC)

  5. Pharmacokinetics of 14C-labeled BVD-523(radioactivity in whole blood and plasma) CL/F [ Time Frame: Collected over 15 days ]
    Oral Clearance (CL/F)

  6. Pharmacokinetics of 14C-labeled BVD-523(radioactivity in whole blood and plasma) V/F [ Time Frame: Collected over 15 days ]
    Apparent volume of distribution (V/F)

  7. Excretion rate of 14C-labeled BVD-523(radioactivity in feces) [ Time Frame: Collected over 15 days ]
    Percent of dose excreted in feces

  8. Excretion rate of 14C-labeled BVD-523(radioactivity in urine) [ Time Frame: Collected over 15 days ]
    Percent of dose excreted in urine

  9. Pharmacokinetics of BVD-523 (in urine) CLR [ Time Frame: Collected over 15 days ]
    Renal clearance (CLR)

  10. Excretion rate of 14C-labeled BVD-523 (radioactivity in vomit, if applicable) [ Time Frame: Collected in 15 days ]
    Percent of dose in vomit, if applicable

  11. Metabolite identification of BVD-523 in plasma, urine and feces [ Time Frame: Collected in 15 days ]
  12. cumulative whole blood: plasma ratio calculated for AUC0-tlast [ Time Frame: Collected in 15 days ]
    AUC from time zero to the last time point with concentration above the lower limit of quantitation

  13. Cumulative whole blood: plasma ratio calculated for AUCinf [ Time Frame: Collected in 15 days ]
    AUC from time zero to infinity


Secondary Outcome Measures :
  1. Treatment-related adverse events [ Time Frame: 27 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males, between 18 and 65 years of age, inclusive, at Screening
  • Have a body mass index range of 18.5 to 32.0 kg/m2, inclusive, at Screening
  • In good health, determined by no clinically significant findings from medical history, 12‑lead ECG, and vital signs measurements at Screening or Check-in and PE findings at Check-in as determined by the Investigator (or designee)
  • Clinical laboratory evaluations (including clinical chemistry panel [fasted at least 8 hours], hematology/complete blood count [CBC], and urinalysis [UA] within the reference range for the test laboratory at Screening and Check‑in, unless deemed not clinically significant by the Investigator (or designee)
  • Negative test for selected drugs of abuse and cotinine at Screening (does not include alcohol) and at Check‑in (does include alcohol)
  • Negative hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens at Screening
  • Males will be surgically sterile for at least 90 days (confirmed by documented azoospermia) or, when sexually-active with female partners of child-bearing potential, will agree to use contraception as detailed in Section 6.3.3 from Check-in until 90 days following Discharge
  • Males must be willing to refrain from sperm donation from Check-in to 90 days from day of dosing
  • Able to comprehend and willing to sign an ICF
  • A minimum of 1 bowel movement per day.

Exclusion Criteria:

  • Significant history or clinical manifestation of any metabolic, allergic, infectious, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator [or designee]) prior to Check‑in
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) prior to Check‑in
  • History of stomach or intestinal surgery or resection that could alter absorption or excretion of orally administered drugs prior to Check‑in except appendectomy, and hernia repair will be allowed if it was not associated with;
  • History of Gilbert's Syndrome
  • History or presence of an abnormal ECG that, in the Investigator's (or designee's) opinion, is clinically significant
  • History of alcoholism or drug addiction within 1 year prior to Check‑in
  • History of nicotine use within 6 months prior to Check-in or positive cotinine at Screening or Check-in
  • Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in. The previous radiolabeled study drug must have been received more than 6 months prior to Check‑in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe, per United States (US) Title 21 Code of Federal Regulations (CFR) 361.1 (eg, less than 3,000 mrem whole body annual exposure)
  • Exposure to significant radiation (eg, serial x‑ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check‑in
  • Use of any drugs or substances known to be strong inhibitors or strong inducers of CYP3A enzyme within 30 days prior to study drug administration, unless otherwise stated, and throughout the study
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days prior to Check‑in, whichever is longer
  • Use of any prescription medications/products within 14 days prior to Check‑in, unless deemed acceptable by the Investigator (or designee)
  • Use of any over-the-counter, nonprescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check‑in, unless deemed acceptable by the Investigator (or designee)
  • Poor peripheral venous access prior to Check‑in
  • Donation of whole blood from 56 days prior to Screening through Discharge, inclusive, or of plasma from 30 days prior to Screening through Discharge, inclusive
  • Receipt of blood products within 2 months prior to Check‑in
  • Any acute or chronic condition that, in the opinion of the Investigator (or designee), would limit the subject's ability to complete or participate in this clinical study
  • Any other unspecified reason that, in the opinion of the Investigator (or designee) or Sponsor, make the subject unsuitable for enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994732


Sponsors and Collaborators
BioMed Valley Discoveries, Inc
Investigators
Principal Investigator: Irene Mirkin, MD Covance

Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT02994732     History of Changes
Other Study ID Numbers: 523HV001
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No