Phase 1 Study to Evaluate ASN002 Absorption, Metabolism, and Excretion of [14C] Following a Single Oral Dose in Healthy Male Subjects

NCT03641573 | Completed Phase 1 FDA Drug

• 1 other identifier: ASN002AD-102
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of \[14C\] ASN002 Following a Single Oral Dose in Healthy Male Subjects

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (8)

• Cmax - maximum observed plasma concentration (plasma and whole blood)

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

• tmax - time at which Cmax occurs (plasma and whole blood)

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

• AUC0 t - area under the plasma concentration time curve from time zero to the last measurable concentration (plasma and whole blood)

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

• AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity (plasma and whole blood)

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

• t½ - apparent terminal elimination half-life (plasma and whole blood)

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

• CL/F - apparent total clearance (plasma and whole blood)

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

• VZ/F - apparent volume of distribution (plasma and whole blood)

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

• Total radioactivity in urine and feces

  %Ae (urine), %Ae (feces) and %Ae (total): amount excreted and cumulative amount excreted in urine and feces

  at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.

Secondary Outcomes (2)

• Metabolic Profiling/identification and determination of relative abundance of ASN002 and the metabolites of ASN002 in plasma, urine, and feces

  Up to 10 days

• Safety and tolerability as measured by incidence and severity of adverse events (AEs)

  Up to 10 days

Study Arms (1)

[14C] ASN002

EXPERIMENTAL

\[14C\] ASN002

Drug: [14C] ASN002

Interventions

[14C] ASN002 DRUG

\[14C\] ASN002

[14C] ASN002

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, of any race, between 20 and 60 years of age, inclusive, at Screening.
• Body mass index between 18.5 and 30.0 kg/m2, inclusive, at Screening.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening or Check in as assessed by the Investigator (or designee).
• Males will agree to use contraception as defined in the Protocol body
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
• History of a minimum of 1 bowel movement per day.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will not be allowed).
• History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
• Consumption of alcohol from 72 hours prior to Check-in until Discharge.
• Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges from 7 days prior to Check-in until Discharge.
• Consumption of caffeine containing foods and beverages from 48 hours before Check-in until Discharge.
• Positive urine drug screen (including cotinine) at Screening or positive alcohol breath test or positive urine drug screen (including cotinine) at Check in.
• Positive hepatitis panel and/or positive human immunodeficiency virus test.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to Check-in.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or excretion processes, including St. John's wort, within 14 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any prescription medications/products within 14 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use slow release medications/products considered to still be active within 14 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
• Use of tobacco or nicotine containing products within 3 months prior to Check in.

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

gusacitinib

Study Officials

• Niranjan Rao, PhD

  Asana BioSciences

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 22, 2018
• Study Start: October 11, 2018
• Primary Completion: October 21, 2018
• Study Completion: October 21, 2018
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)