A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529
- Registration Number
- NCT03400995
- Lead Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Arm AK0529 Each subject will receive a single oral administration of a solution containing 300 mg radiolabeled AK0529 in the fasted state.
- Primary Outcome Measures
Name Time Method Amount excreted (Ae) At approximately 6 weeks The amount of total radioactivity eliminated.
Percentage of cumulative recovery of the administered dose (Cum%Ae) At approximately 6 weeks The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Percentage of the administered dose (%Ae) At approximately 6 weeks The amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Cumulative recovery (CumAe) At approximately 6 weeks The cumulative amount of total radioactivity eliminated.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects with Adverse Events (AEs) From baseline up to approximately 6 weeks An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Trial Locations
- Locations (1)
Quotient Clinical
🇬🇧Nottingham, United Kingdom