Clinical trial · Interventional
Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects
A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy 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 Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipatasertib (capsule) | Drug | Ipatasertib | ALIAS |
| Ipatasertib (tablet) | Drug | Ipatasertib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Sequence 1: Tablet/Capsule/Tablet with food
- description
- Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.
- interventionNames
- Drug: Ipatasertib (capsule)
- Drug: Ipatasertib (tablet)
- type
- EXPERIMENTAL
- label
- Sequence 2: Tablet/Tablet with food/Capsule
- description
- Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast.
- interventionNames
- Drug: Ipatasertib (capsule)
- Drug: Ipatasertib (tablet)
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy males or females, between 18 and 55 years of age, inclusive * Body mass index between 18.5 and 29.9 kg/m\^2, inclusive Exclusion Criteria: \- Clinically significant findings from medical history or screening evaluations.
References
Publications (1)
- DERIVEDMalhi V, Budha N, Sane R, Huang J, Liederer B, Meng R, Patel P, Deng Y, Cervantes A, Tabernero J, Musib L. Single- and multiple-dose pharmacokinetics, potential for CYP3A inhibition, and food effect in patients with cancer and healthy subjects receiving ipatasertib. Cancer Chemother Pharmacol. 2021 Dec;88(6):921-930. doi: 10.1007/s00280-021-04344-9. Epub 2021 Sep 1. PMID 34471960