Health TrialsbyHealthPanel

A Study to Evaluate Different Oral Formulations of KT-621

ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorKymera Therapeutics, Inc.

About this trial

This is a Phase I study to evaluate the relative bioavailability and safety and tolerability of different oral formulations of KT-621 in healthy adult participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants with a weight of at least 50 kilograms (kg) if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at Screening.

Participants must be willing and able to read, understand, and sign an informed consent form (ICF) which includes compliance with requirements and restrictions listed in the ICF and in this protocol.

Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Disqualifiers

Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders.

Participants who have a clinically relevant surgical history (for example, surgery of the GI tract that could interfere with the PK of the study medication). Note: prior appendectomy or cholecystectomy is not exclusionary.

Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.

Participants who have acute GI symptoms at the time of Screening or admission to the CRU (for example, nausea, vomiting, diarrhea, heartburn).

Trial design

Design model

Crossover

Treatments tested in this trial

  • KT-621

    Drug

    KT-621 Reference Oral Formulation

  • KT-621

    Drug

    KT-621 Test Oral Formulation #1

  • KT-621

    Drug

    KT-621 Test Oral Formulation #2

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Part A: KT-621 Test Formulation #1Experimental treatment 1 intervention
Group B: Part B: KT-621 Test Formulation #2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Plasma Concentration (Cmax) of KT-621

Time frame
Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
2

Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KT-621

Time frame
Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
3

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of KT-621

Time frame
Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)

Secondary outcomes

1

Incidence of adverse events

Time frame
From signing of the ICF through the safety follow-up on Day 33 (Part A) or Day 39 (Part B)
2

Incidence of serious adverse events

Time frame
From signing of the ICF through the safety follow-up visit on Day 33 (Part A) or Day 39 (Part B)

Other outcomes

Sponsors and contacts

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

Kymera Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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