A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects

June 8, 2021 updated by: Ark Biosciences Inc.

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Multiple Oral Doses of AK3280 on Renal Function in Healthy Subjects

AK3280 is being developed to further improve the long-term efficacy and tolerability of treatment options for patients with fibrotic disorders.This study will evaluate the effect of AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo in healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • CTC Clinical Trial Consultants AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to give full written informed consent for participation in the study.
  • Healthy male or female subject aged 18-45 years inclusive.
  • Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2。
  • Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator in agreement with the Medical Monitor.
  • With normal renal function defined as mean plasma eGFR ≥80 mL/min/1.73 m2 at screening.
  • Male subjects and applicable female subjects must agree to use effective contraceptive methods to prevent drug exposure of a partner and pregnancy.

Exclusion Criteria:

  • History of allergy to iohexol or other contrast media, to iodine or to shellfish.
  • History of any clinically significant disease or disorder or any other condition that in the opinion of the Investigator renders them unsuitable to participate in the study.
  • Regular use of any prescribed or non-prescribed medication within two weeks prior to the (first) administration of IMP.
  • Any significant elevation at screening or on Day -2 of liver or urinary or serum or plasma renal test results.
  • Subjects with poor venous access.
  • Subjects who have smoked cigarettes (including vapour cigarettes), cigars, and/or used nicotine-containing products within 3 months prior to their screening visit.
  • Positive screen for a drug of abuse or alcohol at screening or prior to administration of the IMP.
  • Subjects who have not abstained from caffeine-containing beverages or products from at least 48 hours prior to screening.
  • An abnormal diet within the 30 days prior to the first study drug dose.
  • Any use of protein powders, xanthine and/or taurine containing energy drinks within 48 hours prior to screening.
  • Blood donation (or corresponding blood loss) during the three months prior to screening.
  • Employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
  • Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AK3280 (Cohort 1)
Subjects in Cohort 1 are administered with an oral dose of 100 mg AK3280 b.i.d from Day 1 to Day 14.
Drug: AK3280
Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
Experimental: AK3280 (Cohort 2)
Subjects in Cohort 2 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 2 will be based on the emerging data from previous cohort.
Drug: AK3280
Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
Experimental: AK3280 (Cohort 3)
Subjects in Cohort 3 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 3 will be based on the emerging data from previous cohorts.
Drug: AK3280
Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
Placebo Comparator: Placebo
For assessment of the Adverse Event (AE) profile, there are placebo controls in each dose cohort.
Drug: Placebo
Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Directly measured absolute glomerular filtration rate (mGFR) results.
Time Frame: Days -1, 7, and 14.
The effect of AK3280 treatment on GFR is measured by iohexol plasma clearance.
Days -1, 7, and 14.
Change from baseline mGFR results.
Time Frame: Days 7 and 14.
To compare the difference of effect of AK3280 treatment on GFR.
Days 7 and 14.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency, intensity, and seriousness of Adverse Events (AEs)
Time Frame: From Day -1 to Day 28.
An AE can be any unfavorable and unintended sign (including an abnormal safety laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
From Day -1 to Day 28.
Change in blood renal function biomarkers
Time Frame: Screening, Days -2, 7, 14, and 21.
Blood renal function biomarkers include cystatin C, beta-trace protein, p-myoglobin, etc.
Screening, Days -2, 7, 14, and 21.
Change in urine renal function biomarkers
Time Frame: From Day -1 to Day 21.
Urine renal function biomarkers include electrolytes, albumin, alpha1-microglobulin, etc.
From Day -1 to Day 21.
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Days 1, 7, and 14.
The maximum observed plasma concentration of AK3280 and its major metabolite, AK3280-M2.
Days 1, 7, and 14.
Concentration at the end of the dosing interval (Ctau)
Time Frame: Days 1, 7, and 14.
The concentration of AK3280 and its major metabolite, AK3280-M2, at the end of the dosing interval.
Days 1, 7, and 14.
trough plasma concentration (Ctrough)
Time Frame: Days 1, 7 and 14.
The trough observed plasma concentration of AK3280 and its major metabolite, AK3280-M2.
Days 1, 7 and 14.
trough plasma concentration (Ctrough)
Time Frame: Days 1, 7, and 14.
The trough observed plasma concentration of AK3280 and its major metabolite, AK3280-M2.
Days 1, 7, and 14.
Area under the plasma concentration-time curve from time zero up to time (AUC 0-t)
Time Frame: Days 1, 7, and 14.
The area under the plasma concentration-time curve from time zero up to the last analytically quantifiable concentration of AK3280.
Days 1, 7, and 14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ark Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK3280-4001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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