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

Shanghai Ark Biopharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: AK0529

Study type

Interventional

Funder types

Industry

Identifiers

NCT03400995

AK0529-4001

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

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