GS1-144 in Participants With Hepatic Impairment and Healthy Female
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
GS1-144 in Participants with Hepatic Impairment and Healthy Female
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements。
Female participants aged 18-70 years (inclusive) (age-matched between the normal hepatic function group and the hepatic impairment groups, mean ±10 years).
Females of childbearing potential who are willing to use adequate and effective contraception from the date of signing the ICF until 1 month after administration of the investigational drug.
Body weight ≥ 45.0 kg (body weight matched between the normal hepatic function group and the hepatic impairment groups, mean body weight ±10 kg), with BMI within 18.0-32.0 kg/m2 (inclusive).
Disqualifiers
Allergic constitution (e.g., allergy to more than two drugs or foods), or a history of allergy to the investigational drug or any excipients thereof.
Use of tobacco-containing products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study.
Alcohol abuse within 3 months prior to screening (weekly consumption ≥ 14 units of alcohol: 1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or unwillingness to stop drinking during the study.
Blood loss or donation of ≥ 450 mL of whole blood or plasma within 3 months prior to screening, or receipt of any transfusion of blood or blood products within 60 days.
Trial design
Design model
Single group
Treatments tested in this trial
GS1-144 tablet
DrugAdministered a single oral dose with GS1-144 tablet 30mg
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: GS1-144 tabletExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum concentration (Cmax) of GS1-144 Cmax will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 42
Area under the curve from time 0 to the last time with quantifiable concentration (AUC0-t ) of GS1-144 AUC0-t will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 43
Area under the curve from time 0 to infinity (AUC0-∞) of GS1-144 AUC0-∞ will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 44
Time to maximum concentration (Tmax) of GS1-144 Tmax will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 4Secondary outcomes
1
Apparent volume of distribution (Vz/F) of GS1-144 Vz/F will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 42
Cmax of metabolite M1. Cmax of metabolite M1 will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 43
AUC0-t of metabolite M1. AUC0-t of metabolite M1 will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 44
AUC0-∞ of metabolite M1. AUC0-∞ of metabolite M1 will be assessed and reported.
Time frame
From time of taking the GS1-144 up to day 4Sponsors and contacts
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Source ClinicalTrials.gov
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