Clinical trial · Interventional
DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin
A Phase 1, Single-center, Open-label, 2-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Rosuvastatin (Crestor®), a Sensitive Breast Cancer Resistance Protein (BCRP) Substrate, in Healthy Male and Female Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male and female subjects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment A (rosuvastatin) | Drug | — | UNRESOLVED |
| Treatment B (LX4211) | Drug | — | UNRESOLVED |
| Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment A
- description
- 10 mg oral rosuvastatin administration
- interventionNames
- Drug: Treatment A (rosuvastatin)
- type
- EXPERIMENTAL
- label
- Treatment B
- description
- 400 mg oral LX4211 qd administration
- interventionNames
- Drug: Treatment B (LX4211)
- type
- EXPERIMENTAL
- label
- Treatment C
- description
- 10 mg oral rosuvastatin administration + 400 mg oral LX4211 qd administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Adult subjects ≥18 to ≤55 years of age * Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm * Body mass index (BMI) ≥18 and ≤32 kg/sq m * Willing and able to provide written informed consent Exclusion Criteria: * Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results * Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study * Receipt of any investigational agent or study drug within 30 days prior to Screening * Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening * Prior exposure to LX4211 * Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study * History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or rosuvastatin * Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or rosuvastatin * History of any major surgery within 6 months or anticipated surgery prior to Day * History of any clinically significant hypoglycemia or hyperglycemia * History of renal disease, or significantly abnormal kidney function test at Screening * History of hepatic disease, or significantly abnormal liver function tests at Screening * History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality * History of any active infection within 14 days prior to Day 1 * History of alcohol or substance abuse within 2 years prior to Screening * Positive hepatitis panel * Donation or loss of \>500 mL of blood or blood product within 3 months prior to Screening * Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test * Positive urine glucose at Screening * Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13 * Inability or difficulty swallowing whole tablets * Unable or unwilling to cooperate with the Investigator for any reason
References
Publications (0)
Data not yet available