Renal ImpairmentPhase 1NCT05916573

A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment

A Phase 1 study testing HSK16149 in people with Renal Impairment, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of HSK16149 in subjects with mild, moderate and severe renal impairment compared to the matched control subjects with normal renal function. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: HSK16149
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteChina
Study dates: 12 Dec 2022to 26 Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects with renal impairment(RI):
Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
18 years to 75 years (inclusive), male and female;
Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m^2));
Subjects with medically stable RI until study completion corresponding to the classifications of Renal Function based on GFR: mild RI: 60≤GFR<90 mL/min; moderate RI: 30≤GFR<60 mL/min, severe RI:15≤GFR<30 mL/min;
Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;

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Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for RI/ other comorbidities (last more than four weeks in good compliance);
Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.
Subjects with normal renal function :
Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
18 years to 75 years (inclusive), male and female, age and sex must be matched with subjects with RI;
Male subjects weight ≥50 kg and female subjects weight ≥45 kg, weight must be matched with subjects with RI. Body mass index (BMI) : 18-30 kg/m^2 (inclusive) (BMI= weight (kg)/height2 (m^2));
90≤GFR<130 mL/min;
Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;
Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for comorbidities (last more than four weeks in good compliance);
Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.

Who cannot join

Allergic to any component in HSK16149 capsules;
Uncontrolled or unstable cardiovascular, respiratory, liver, gastrointestinal tract, endocrine, blood, mental/nervous, etc.Systemic diseases;
Those who have committed suicide or suicidal tendency in the past, or those who have recurrent dizziness, headache, memory and cognitive impairment;
According to the researcher's judgment, there are factors that affect the absorption, distribution, metabolism and excretion of drugs, such as diseases, drugs, surgery, etc.; Taking Niaoduqing granules, the stool is irregular or shapeless;
Acute renal failure;
Smoking more than 5 cigarettes a day on average in the 3 months before screening or unable to stop using any tobacco products during the test period;

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Drinking more than 14 units per week within 3 months before screening (1 unit = 17.7 mL ethanol, that is, 1 unit =357 mL beer with 5% alcohol content, 43 mL white wine with 40% alcohol content or 147 mL wine with 12% alcohol content), or those who can't ban alcohol during the test, or those who are positive in alcohol breath test;
Have a history of drug abuse within 5 years before screening, or have a positive drug abuse screening;
Those who have ingested beverages or foods rich in xanthine (coffee, tea, chocolate, etc.) or grapefruit for a long time in the past, or have taken any products rich in xanthine or grapefruit orally within 48 hours before administration;
Those who have participated in any clinical trials of drugs or medical devices within 3 months before screening (subject to administration).
The amount of blood donation (or blood loss) within 3 months before screening is ≥400 mL, or those who have received blood products to improve anemia;
One of ALT and/or AST >2*ULN, total bilirubin > 1.5* ULN and creatine kinase > 2*ULN during screening;
Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
Female subjects who are pregnant or lactating or whose serum pregnancy results are positive during the screening period or during the trial;
Subjects considered by the researcher to have any factors that are not suitable for participating in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital of Sichuan University
Chengdu, Sichuan

Other trials in China

About this study

Conditions: Renal Impairment
Being tested: HSK16149
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HSK16149Drug
single oral adminiatration, 20mg

Study groups in NCT05916573
Study group	Role	What they receive
Mild Renal Impairment	Experimental	Not described Receives: Drug: HSK16149
Moderate Renal Impairment	Experimental	Not described Receives: Drug: HSK16149
Severe Renal Impairment	Experimental	Not described Receives: Drug: HSK16149
Normal Renal function	Experimental	Not described Receives: Drug: HSK16149

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
The maximun plasma concentration of HSK16149
Measured: From the start to 72 hours after administration
AUC0-t
Area under the concentration-time curve from time zero to time of last quantifiable concentration
Measured: From the start to 72 hours after administration
AUC0-inf
Area under the concentration-time curve from time zero extrapolated to infinite time
Measured: From the start to 72 hours after administration

Secondary outcomes (7)

Tmax
Time of maximum concentration
Measured: From the start to 72 hours after administration
t1/2
half-life
Measured: From the start to 72 hours after administration
CL
Plasma clearance
Measured: From the start to 72 hours after administration
Vz
Volume of distribution associated with the terminal phase
Measured: From the start to 72 hours after administration
Ae
Cumulative urinary recovery of unchanged drug
Measured: From the start to 72 hours after administration
Fe
Cumulative urinary recovery fraction of unchanged drug
Measured: From the start to 72 hours after administration
CLr
Renal clearance
Measured: From the start to 72 hours after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 202226 Apr 2023

First posted23 Jun 2023
Study start12 Dec 2022
Primary completion27 Feb 2023
Study completion26 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05916573
Sponsor's protocol ID: HSK16149-104
Status last verified: Oct 2022
First submitted: 14 Jun 2023
Last updated: 23 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment
ClinicalTrials.gov ID: NCT05916573
Acronym / sponsor ID: HSK16149-104
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 12 Dec 2022 (actual)
Primary completion: 27 Feb 2023 (actual)
Study completion: 26 Apr 2023 (actual)
First posted: 23 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Mild Renal Impairment	Experimental	Drug: HSK16149
Moderate Renal Impairment	Experimental	Drug: HSK16149
Severe Renal Impairment	Experimental	Drug: HSK16149
Normal Renal function	Experimental	Drug: HSK16149

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Subjects with renal impairment(RI):
Subjects with normal renal function :

Key exclusion criteria (15 listed)

Allergic to any component in HSK16149 capsules;
Uncontrolled or unstable cardiovascular, respiratory, liver, gastrointestinal tract, endocrine, blood, mental/nervous, etc.Systemic diseases;
Those who have committed suicide or suicidal tendency in the past, or those who have recurrent dizziness, headache, memory and cognitive impairment;
According to the researcher's judgment, there are factors that affect the absorption, distribution, metabolism and excretion of drugs, such as diseases, drugs, surgery, etc.; Taking Niaoduqing granules, the stool is irregular or shapeless;
Acute renal failure;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HSK16149single oral adminiatration, 20mg	Drug	Mild Renal Impairment, Moderate Renal Impairment, Normal Renal function, Severe Renal Impairment

Primary outcome

Cmax
Time frame: From the start to 72 hours after administration
The maximun plasma concentration of HSK16149
AUC0-t
Time frame: From the start to 72 hours after administration
Area under the concentration-time curve from time zero to time of last quantifiable concentration
AUC0-inf
Time frame: From the start to 72 hours after administration
Area under the concentration-time curve from time zero extrapolated to infinite time

7 secondary outcomes

Tmax
Time frame: From the start to 72 hours after administration
t1/2
Time frame: From the start to 72 hours after administration
CL
Time frame: From the start to 72 hours after administration
Vz
Time frame: From the start to 72 hours after administration
Ae
Time frame: From the start to 72 hours after administration
Fe
Time frame: From the start to 72 hours after administration
CLr
Time frame: From the start to 72 hours after administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK16149 in people with Renal Impairment, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: From the start to 72 hours after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.