A Phase I, open-label study in healthy participants aged 18 to 65 years to investigate the CYP3A4 induction potential of GSK3882347

GlaxoSmithKline (United Kingdom)0 sites30 target enrollmentMarch 24, 2023

ConditionsHealthy volunteer drug interaction study Not Applicable

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteer drug interaction study
Sponsor: GlaxoSmithKline (United Kingdom)
Enrollment: 30
Status: Suspended
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 24, 2023

End Date

May 3, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

GlaxoSmithKline (United Kingdom)

Eligibility Criteria

Inclusion Criteria

•1\. Participants must be \=18 years of age and \=65 years of age at the time of signing the informed consent.
•2\. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion or exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor (if required), agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
•3\. Body weight at least 50\.0 kg (110 lbs) for males and 45\.0 kg (99 lbs) for females; and body mass index (BMI) within the range 18\.5 – 32\.0 kg/m² (inclusive).
•4\. Male and female participants
•4\.1\. Male Participants: Male participants are eligible to participate if they agree to the following during the study intervention Period and for at least 3 days, after the last dose of study intervention:
•4\.1\.1\. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long\-term and persistent basis) and agree to remain abstinent OR
•4\.1\.2\. Must agree to use contraception/barrier as detailed below:
•\- Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
•\- Agree to use a male condom when engaging in any activity that allows for the passage of ejaculate to another person.
•4\.2\. Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

Exclusion Criteria

•1\. History or presence of significant cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, metabolic, endocrinological, hematological, immunologic, dermatologic, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data or in the opinion of the investigator places the subject at unacceptable risk or would make adhering to study procedures for the duration of the study difficult. Participants who have had a gastric bypass or a cholecystectomy are excluded from the study.
•2\. Abnormal blood pressure, as determined by the investigator.
•3\. Alanine transferase (ALT) value \>1\.5 × ULN.
•4\. Bilirubin value \>1\.5 × ULN (isolated bilirubin \>1\.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
•5\. The participant has a current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
•6\. The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval.
•7\. The participant has any history of heart failure.
•8\. The participant has a family history of QT prolongation or sudden death.
•9\. The participant has any current or previous history of episodes of symptomatic bradycardia or bradyarrhythmia.
•10\. The participant has a QTc \>450 msec. Note: The QTc is the QT interval corrected for heart rate according to the Fridericia formula, machine, or manual overread.