An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143

Completed · Phase 1

Conditions studied: Severe Hepatic Impairment

In brief

Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet the full study eligibility criteria will be enrolled into the study. For each participant with severe hepatic impairment, a corresponding healthy participant will be enrolled who matches with regard to age, sex, and BMI. A single dose of 55-mg EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in the study center for collection of blood samples and safety monitoring. Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments. The study will measure and describe the concentrations of EQ143 and its metabolite (HAS-719) in plasma over the course of 9 days (including calculation of PK parameters), the degree of EQ143 and metabolite HAS-719 (and other metabolites, if applicable) binding to proteins in plasma, and the safety of administering a single dose of EQ143 in severely hepatically impaired and matched healthy participants

Key facts

Study ID

NCT05199610

Run by

EQRx International, Inc.

People needed

12

Starts

2022-03-30

Expected to finish

2023-04-01

Last updated by the study team

2023-04-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Main Criteria for Inclusion: All Participants
• Must be willing to participate in the study and sign the informed consent form (ICF).
• Must be willing and able to complete all study-specific procedures and visits.
• Is 18 to 75 years of age, inclusive, at Screening.
• Is able to take and swallow oral medication.
• BMI of 18.0 to 42.0 kg/m2
• High probability for compliance with and completion of the study, in the opinion of the Investigator.
• Must meet all of the applicable requirements for pregnancy and contraception, as follows:
• If female:
• Is a female participant of childbearing potential who:
• Has a negative serum pregnancy test result within 48 hours before Day -1;
• Is not breastfeeding;
• Agrees to use highly effective contraceptive measures during heterosexual intercourse throughout the study and for 12 weeks following EQ143 administration; AND
• Agrees not to donate ova for the same time period; OR
• Is a participant of non-childbearing potential, as confirmed by meeting both of the following criteria:
• Has a negative serum or urine pregnancy test result within 48 hours before Day -1; AND is confirmed by the Investigator to be medically postmenopausal per one or more of the following parameters:
• Age, in addition to any of the other parameters listed here;
• Menses status (absence of menses for ≥ 1 year); or
• Surgical status (prior hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), with participant providing documentation of the surgical sterilization procedure (by operative report or ultrasound scan) prior to EQ143 administration; or
• Follicle-stimulating hormone (FSH) level.
• If male:
• Agrees to use a highly effective method of contraception (eg, male condom in addition to hormonal contraception) during heterosexual intercourse throughout the study and for 12 weeks following EQ143 administration; AND
• Agrees to refrain from donating sperm for the same time period. Note: For all study participants, contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Main Criteria for Inclusion: Hepatically Impaired Participants

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Main Criteria for Exclusion: All Medical History
• Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death.
• Presence or history of any disorder that may prevent the successful completion of the study.
• Current or recent (within 3 months of Day 1 of the study) gastrointestinal disease that could impact the absorption of EQ143.
• History of drug abuse within 1 year before Day 1 of the study
• Is a regular smoker (ie, smokes more than 5 cigarettes per day or more than 10 packets per year), and is not willing to refrain from smoking from 48 hours before EQ143 administration through the final study visit.
• Allergies and Adverse Drug Reactions
• History of any clinically important drug allergy or adverse drug reaction. Physical and Laboratory Findings
• Plasma potassium and/or magnesium values outside the normal range.
• Note: At the discretion of the Investigator, these tests may be repeated to confirm a result that is outside the normal range; repeat test results must be within normal limits to confirm participant eligibility.
• An automatic ECG absolute QT interval with Fridericia's correction (QTcF) reading at Screening of > 480 ms (males) or > 500 ms (females).
• Has evidence of active bacterial, fungal, or viral infection (including human immunodeficiency virus [HIV] or SARS-CoV-2, as detailed below) which would preclude safe enrollment as assessed by the treating Investigator.
• Note regarding HIV: Participants with positive serologic finding and detectable HIV are excluded; however, participants with undetectable HIV and a viral load of 0 are not excluded if meeting all other eligibility criteria.
• Note regarding SARS-CoV-2: The study SARS-CoV-2 requirements are determined by institutional standards (and local/country regulations, as applicable).
• At Investigator discretion, any participant who tests positive and/or is symptomatic for SARS-CoV-2 during Screening may either be excluded from the study or delay enrollment until active infection has been excluded per institutional standards.
• During the study, any SARS-CoV-2 testing is to be performed as clinically indicated for the individual participant. The Investigator must document the results of all tests performed. Any confirmed infection is to be recorded as an AE or, in the event that clinical manifestation warrants such, recorded and handled as an SAE as detailed.
• Positive finding on urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cocaine, opiates), except a) cannabinoids or b) substances that are not prohibited per protocol and are legally prescribed to the participant, and have therefore been documented as concomitant medications (with additional considerations as noted below).
• Note: Any participant who is taking any prescribed substance that triggers a positive urine drug screen result must have potential drug abuse ruled out by the Investigator. Additionally, any such participant must be confirmed by the Investigator to meet all other study eligibility criteria to rule out any potential excluded comorbidities associated with the prescribed substance.
• Prohibited Treatments
• Consumption of alcoholic beverages from 24 hours before Day 1 of the study through the final study visit.
• Consumption of grapefruit or grapefruit-containing products from 72 hours before Day 1 of the study through the final study visit.
• Donation of blood within 30 days before Day 1 of the study.
• Involvement in another investigational study of any type within 30 days before EQ143 administration
• Main Criteria for Exclusion: Hepatically Impaired Participants Medical History

Where it is running

• American Institute Research — Los Angeles, California, United States
• Global Clinical Professionals — St. Petersburg, Florida, United States
• Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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