Clinical trial NCT03400995: A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529
Official title: An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-AK0529 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 7
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Amount excreted (Ae)
timeFrame: At approximately 6 weeks
measure: Percentage of the administered dose (%Ae)
timeFrame: At approximately 6 weeks
measure: Cumulative recovery (CumAe)
timeFrame: At approximately 6 weeks
measure: Percentage of cumulative recovery of the administered dose (Cum%Ae)
timeFrame: At approximately 6 weeks
Secondary outcomes:
measure: Percentage of Subjects with Adverse Events (AEs)
timeFrame: From baseline up to approximately 6 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: info@arkbiosciences.com
name: ArkBio Clinical Trial
role: STUDY_DIRECTOR
References: