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An Open Label, Single-Dose Study of 14C-NW-3509 in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT03446274
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Newron Pharmaceuticals SPA

Brief Summary:
This is a single-center, open-label, non-randomized, single dose of 14C-NW-3509 capsule study in 6 healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Evenamide Phase 1

Detailed Description:
This is a single-center, open-label, non-randomized, single dose study in a single cohort of 6 healthy male subjects, including up to 2 cytochrome P450 (CYP)2D6 poor metabolizer subjects. Each subject will receive a single oral administration of 14C-NW-3509 capsule in the fasted state.The screening period and study admission to completion is estimated to be up to 43 days. The following data will be analyzed urine and feces data for total radioactivity, plasma and whole blood data for total radioactivity and plasma concentration data for NW-3509.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-NW-3509 in Healthy Male Subjects
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Intervention Details:
    Drug: Evenamide
    This is an orally available small molecule that potently blocks voltage-gated sodium channels (VGSCs) in vitro and is indicated for the treatment of patients with schizophrenia, mania, and bipolar disorder.


Primary Outcome Measures :
  1. Metabolic profiling for NW-3509 will be determined in plasma, urine and fecal samples [ Time Frame: 15 days ]
    Percent of each radio labeled drug-related material will be determined in plasma, urine and feces


Secondary Outcome Measures :
  1. Routes and rate of elimination of NW-3509 in plasma, urine and feces [ Time Frame: 15 days ]
    The routes and rate of elimination of 14C-NW-3509 by measurement of 14C-NW-3509 and its major metabolites in plasma, urine and feces

  2. The identification of major metabolites of NW-3509 in plasma, urine and feces [ Time Frame: 15 days ]
    Metabolic profiling will be performed using liquid chromatography-radio-detection, with subsequent mass spectrometry

  3. Safety and Tolerability of NW-3509 [ Time Frame: 15 days ]
    This will be assessed by Adverse events, Clinical chemistry, Clinical Hematology and Urinalysis, Vital signs and Physical Examination

  4. Oral Pharmacokinetics of NW-3509 in plasma, urine and feces [ Time Frame: 15 days ]
    Several parameters will be measured Cmax, Tmax, AUC, elimination half-life, Tlag etc



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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males
  2. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  3. Must be willing and able to communicate and participate in the whole study
  4. Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
  5. Subject is considered healthy on the basis of medical history, physical examination, ECG, vital signs and clinical laboratory assessments
  6. Must provide written informed consent
  7. Must adhere to the contraception requirements

Exclusion Criteria:

  1. Subjects who have received any IMP in a clinical research study within the previous 3 months
  2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  3. Subjects who have previously been enrolled in this study
  4. History of any drug or alcohol abuse in the past 2 years
  5. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
  6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission
  7. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  8. Radiation exposure, excluding background radiation but including significant medical exposures, or other trial related exposures, not exceeding 5 mSv in the 12 months preceding participation in the trial, or radiation exposure exceeding 10 mSv in the 5 years preceding participation in the trial, inclusive of the 3 mSv exposure resulting from participation in this study. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study. Significance of a medical exposure will be determined by the investigator.
  9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  10. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
  11. Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
  12. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  13. History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or neurological or psychiatric disorder, as judged by the investigator
  14. Presence or history of seizure disorders or ataxia
  15. History of presence of significant cardiac conduction abnormalities including but not limited to: PR interval >240 msec; QRS duration >120 msec; QTcF interval >450 msec
  16. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  17. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
  18. Donation or loss of greater than 400 mL of blood within the previous 3 months
  19. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration (See Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
  20. Failure to satisfy the investigator of fitness to participate for any other reason

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): NCT03446274


Contacts
Contact: Ravi Anand, MD +41 793741364 ravi@anand.ch

Locations
United Kingdom
Quotient Sciences Recruiting
Nottingham, NG, United Kingdom
Contact: Sharan Sidhu, MRCS         
Contact    +44 (0)115 974 9000      
Sponsors and Collaborators
Newron Pharmaceuticals SPA
Investigators
Principal Investigator: Sharan Sidhu, MRCS Quotient Sciences

Responsible Party: Newron Pharmaceuticals SPA
ClinicalTrials.gov Identifier: NCT03446274     History of Changes
Other Study ID Numbers: NW3509-007
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No