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

NCT ID: NCT03400995

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-05
• Study Completion Date: 2018-08-30

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.

Detailed Description

This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of [14C]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.

Conditions

Healthy

Study Design

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

Study Groups

Intervention Arm

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

Group Type: EXPERIMENTAL

AK0529

Intervention Type: DRUG

A solution containing 300 mg radiolabelled AK0529.

Interventions

AK0529

A solution containing 300 mg radiolabelled AK0529.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Any abnormality of cardiac rhythm or history thereof
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed, unless it is active at screening or admission
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal or any other 'alternative' remedies in the 14 days before IMP administration
• Failure to satisfy the investigator of fitness to participate for any other reason

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ark Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ArkBio Clinical Trial

Role: STUDY_DIRECTOR

info@arkbiosciences.com

Locations

Quotient Clinical

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

AK0529-4001

Identifier Type: -

Identifier Source: org_study_id