A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529

NCT03400995 | Completed Phase 1

• 1 other identifier: AK0529-4001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I study is to assess the mass balance recovery after a single oral dose of \[14C\]-AK0529 in healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Amount excreted (Ae)

  The amount of total radioactivity eliminated.

  At approximately 6 weeks

• Percentage of the administered dose (%Ae)

  The amount of total radioactivity eliminated expressed as a percentage of the dose administered.

  At approximately 6 weeks

• Cumulative recovery (CumAe)

  The cumulative amount of total radioactivity eliminated.

  At approximately 6 weeks

• Percentage of cumulative recovery of the administered dose (Cum%Ae)

  The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.

  At approximately 6 weeks

Secondary Outcomes (1)

• Percentage of Subjects with Adverse Events (AEs)

  From baseline up to approximately 6 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Each subject will receive a single oral administration of a solution containing 300 mg radiolabeled AK0529 in the fasted state.

Drug: AK0529

Interventions

AK0529 DRUG

A solution containing 300 mg radiolabelled AK0529.

Intervention Arm

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Aged between 30 and 55 years of age, inclusive
• Body mass index of 18.0 to 35.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator and the medical monitor
• Must be willing and able to communicate and participate in the whole study
• Must have regular daily bowel movements
• Must provide written informed consent
• Must agree to use an adequate method of contraception

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 or sponsor 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 \>21 units per week
• Current smokers and those who have smoked within the last 12 months
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• Radiation exposure. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
• Abnormal liver function as assessed by clinical chemistry
• Positive drugs of abuse test result
• Positive HBsAg, HCV Ab or HIV results
• Evidence of renal impairment at screening
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, neurological, dermatological or GI disease, or psychiatric disorder, as judged by the investigator
• Any abnormality of ECG parameters

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Quotient Clinical

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

ziresovir

Study Officials

• ArkBio Clinical Trial

  info@arkbiosciences.com

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: January 5, 2018
• Primary Completion: February 27, 2018
• Study Completion: August 30, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)