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

NCT03446274 | Unknown Phase 1 DMC

• 1 other identifier: NW3509-007
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Metabolic profiling for NW-3509 will be determined in plasma, urine and fecal samples

  Percent of each radio labeled drug-related material will be determined in plasma, urine and feces

  15 days

Secondary Outcomes (4)

• Routes and rate of elimination of NW-3509 in plasma, urine and feces

  15 days

• The identification of major metabolites of NW-3509 in plasma, urine and feces

  15 days

• Safety and Tolerability of NW-3509

  15 days

• Oral Pharmacokinetics of NW-3509 in plasma, urine and feces

  15 days

Interventions

Evenamide DRUG

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.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the previous 3 months
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• Subjects who have previously been enrolled in this study
• History of any drug or alcohol abuse in the past 2 years
• 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)
• 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
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• 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.
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
• Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or neurological or psychiatric disorder, as judged by the investigator
• Presence or history of seizure disorders or ataxia
• 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

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG, United Kingdom

RECRUITING

Study Officials

• Sharan Sidhu, MRCS

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ravi Anand, MD

CONTACT

+41 793741364; ravi@anand.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 26, 2018
• Study Start: April 2, 2018
• Primary Completion: April 23, 2018
• Study Completion: June 1, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

GB (1)