Health TrialsbyHealthPanel

A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorImmunome, Inc.

About this trial

This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit

Male participants must follow protocol-specified contraception guidance

Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing

BMI ≥ 18.0 and ≤ 32.0 kg/m2 and with a body weight > 50 kg at the screening visit

Disqualifiers

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

History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee

History of any illness that, in the opinion of the PI or designee might confound the results of the study or poses an additional risk to the participant by their participation in the study

History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing

Trial design

Design model

Crossover

Treatments tested in this trial

  • Varegacestat Reference Formulation

    Drug

    Oral administration

  • Varegacestat Test Formulation

    Drug

    Oral administration

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Reference Formulation, then Test FormulationExperimental treatment 2 interventions
Group B: Test Formulation, then Reference FormulationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Evaluate the rBA of varegacestat by AUC0-t

Time frame
Approximately 3 weeks
2

Evaluate the rBA of varegacestat by AUC0-inf

Time frame
Approximately 3 weeks
3

Evaluate the rBA of varegacestat by Cmax

Time frame
Approximately 3 weeks

Secondary outcomes

1

Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events

Time frame
Approximately 4 weeks
2

Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities

Time frame
Approximately 3 weeks
3

Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline

Time frame
Approximately 3 weeks
4

Assess the safety and tolerability of varegacestat by incidence of changes from baseline of 12-lead ECG assessments

Time frame
Approximately 3 weeks

Other outcomes

Sponsors and contacts

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

Immunome, Inc.

Lead sponsor

Source ClinicalTrials.gov
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