Healthy
Conditions
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.
Interventions
DRUGAK0529
A solution containing 300 mg radiolabelled AK0529.
Sponsors
Shanghai Ark Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount excreted (Ae) | At approximately 6 weeks | The amount of total radioactivity eliminated. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed