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

NCT ID: NCT03641573

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-11
• Study Completion Date: 2018-10-21

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

Detailed Description

This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be confined to the CRU until at least Day 7. On Day 1, subjects will receive a single oral dose of [14C] ASN002 at 60 mg containing approximately 300 μCi [14C] ASN002. Subjects will be discharged on Day 7 if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, and ≥90% mass balance recovery, or ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24 hour periods. If discharge criteria are not met by Day 7, subjects will remain in the CRU up to a maximum of Day 10.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C] ASN002

\[14C\] ASN002

Group Type: EXPERIMENTAL

[14C] ASN002

Intervention Type: DRUG

\[14C\] ASN002

Interventions

[14C] ASN002

\[14C\] ASN002

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Receipt of blood products within 2 months prior to Check in.
• Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
• Poor peripheral venous access.
• Have previously completed or withdrawn from this study or any other study investigating ASN002, and have previously received the investigational medicinal product (IMP).
• Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
• Subjects who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the CFR recommended levels considered safe, per United States Title 21 CFR 361.1: less than 5,000 mrem whole body annual exposure with consideration given to the half-lives of the previous radiolabeled study drugs received.
• Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Asana BioSciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niranjan Rao, PhD

Role: STUDY_DIRECTOR

Asana BioSciences

Locations

Covance Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

ASN002AD-102

Identifier Type: -

Identifier Source: org_study_id