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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641573
• Other study ID #: ASN002AD-102
• Status: Completed
• Phase: Phase 1
• Start date: October 11, 2018
• Est. completion date: October 21, 2018

Study information

• Verified date: May 2020
• Source: Asana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 21, 2018
• Est. primary completion date: October 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• [14C] ASN002
[14C] ASN002

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Asana BioSciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	AUC0-8 - 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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Metabolic Profiling/identification and determination of relative abundance of ASN002 and the metabolites of ASN002 in plasma, urine, and feces		Up to 10 days
Secondary	Safety and tolerability as measured by incidence and severity of adverse events (AEs)		Up to 10 days