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Relative Bioavailability of NX-5948 Tablets vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets

ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorNurix Therapeutics, Inc.

About this trial

This is a multiple part, multiple cohort study evaluating the relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy, adult, male or female 19-55 years of age

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

Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2

Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead safety ECGs at the screening visit, as deemed by the PI or designee

Disqualifiers

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

Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders

History of any gastrointestinal surgery or cholecystectomy that could impact the PK of NX-5948

History or presence of alcohol or drug abuse within the past 2 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • NX-5948

    Drug

    Administered orally in tablet or capsule form

  • Esomeprazole

    Drug

    Administered orally in capsule form

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: NX-5948 tablet and capsule under fasted and fed conditionsExperimental treatment 1 intervention
Group B: NX-5948 tablet and capsule combined with esomeprazole under fasted conditionsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Assessment of PK parameters: NX-5948 tablets versus capsules

Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (AUC)

Time frame
9 weeks
2

Assessment of PK parameters: NX-5948 tablets versus capsules

Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Cmax)

Time frame
9 weeks
3

Assessment of PK parameters NX-5948 tablets versus capsules

Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Tmax)

Time frame
9 weeks
4

Food effect and effect of esomeprazole on AUC0-t for single-dose NX-5948 tablet

Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet

Time frame
9 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Nurix Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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