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Phase 1 Completed N=27 Basic Science

Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants

Healthy Volunteers
Source: ClinicalTrials.gov NCT05134337 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Part 1: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LOXO-305 — 4000; 4100 nanogram per milliliter (ng/mL)

Summary

The main purpose of this study is to learn about how itraconazole and rifampin affect LOXO-305 in healthy participants. Participation could last about 8 weeks.

Outcome Measures

OutcomeResultp-value
PRIMARY
Part 1: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LOXO-305
4000; 4100
PRIMARY
Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305
80000; 122000
PRIMARY
Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305
80800; 123000
PRIMARY
Part 2: PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305
4480; 4170; 2580
PRIMARY
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305
79700; 48500; 23000
PRIMARY
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305
80600; 23600
PRIMARY
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of LOXO-305
50200; 48600

Eligibility Criteria

Inclusion Criteria

  • Males and females of non-childbearing potential.
  • Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
  • Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
  • Able to comply with all study procedures, including the 19-night stay for those participating in Part 1 or 24-night stay for those participating in Part 2 at the Clinical Research Unit and follow-up phone call.

Exclusion Criteria

  • History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
  • liver disease
  • pancreatitis
  • peptic ulcer disease
  • intestinal malabsorption
  • gastric reduction surgery
  • history or presence of clinically significant cardiovascular disease.
  • Participants with out-of-range, at-rest vital signs.
  • Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
  • Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
  • Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
  • Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
  • History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
  • Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
  • Receipt of blood products within 2 months prior to Check-in (Day -1).
  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05134337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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