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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400995
• Other study ID #: AK0529-4001
• Status: Completed
• Phase: Phase 1
• Start date: January 5, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: September 2018
• Source: Ark Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 30, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AK0529
A solution containing 300 mg radiolabelled AK0529.

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Ark Biosciences Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount excreted (Ae)	The amount of total radioactivity eliminated.	At approximately 6 weeks
Primary	Percentage of the administered dose (%Ae)	The amount of total radioactivity eliminated expressed as a percentage of the dose administered.	At approximately 6 weeks
Primary	Cumulative recovery (CumAe)	The cumulative amount of total radioactivity eliminated.	At approximately 6 weeks
Primary	Percentage of cumulative recovery of the administered dose (Cum%Ae)	The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.	At approximately 6 weeks
Secondary	Percentage of Subjects with Adverse Events (AEs)	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.	From baseline up to approximately 6 weeks