Health TrialsbyHealthPanel

Aleniglipron Hepatic Impairment Study

ConditionHepatic Impairment
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

About this trial

The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is an adult, male or female, ≥ 18 to 85 years of age (inclusive), at screening.

Female and male participants must follow protocol-specified contraception guidance as described in Section 5.4.2.1 and Section 5.4.2.2.

Is a continuous non-smoker or smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing. Participants must agree to maintain the same smoking status (i.e., smoker or non-smoker) from screening and until after the last PK sample collection.

BMI ≥ 17.0 and ≤ 40.0 kg/m2 and weight of at least 40.0 kg at screening.

Disqualifiers

Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.

History or presence of alcohol or drug abuse (including participants with symptoms of cannabis disorder) within the past 6 months prior to the dosing.

History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.

Female participant with a positive serum pregnancy test at screening or at check-in or who is lactating or breastfeeding.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Aleniglipron

    Drug

    administered orally

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Participants will receive aleniglipron administered orally Part 1Experimental treatment 1 intervention
Group B: Participants will receive aleniglipron administered orally Part 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PK parameters including but not limited to AUC0-t

Time frame
Baseline to Day 5 (Part 1)
2

PK parameters including but not limited to AUC0-inf

Time frame
Baseline to Day 5 (Part 1)
3

PK parameters including but not limited to Cmax

Time frame
Baseline to Day 5 (Part 1)
4

PK parameters including but not limited to AUC0-t

Time frame
Baseline to Day 5 (Part 2)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: