Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigel Pharmaceuticals
About this trial
A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult male or female ≥ 18 years of age at the time of signing the informed consent form
Must have an Eastern Cooperative Oncology Group performance status ≤ 2.
Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)
Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia [AML], gastrointestinal [GI] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.
Disqualifiers
Female patients who are pregnant or breastfeeding.
Patients who are active smokers. Those who have ceased smoking > 1 month before the Screening Visit will be allowed.
Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.
Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.
Trial design
Design model
Single group
Treatments tested in this trial
Olutasidenib
DrugParticipants will receive repeated dosing of olutasidenib from Day 5 to Day 22 until steady state, with an option to continue treatment up to Day 64
CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
DrugParticipants will receive a single dose of each probe substrate on Day 1 and Day 18.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 SubstratesExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Area Under the Plasma Concentration-Time Curve (AUC) of Probe Drugs
To evaluate how olutasidenib affects the overall exposure of several test drugs (probe substrates) that are used to measure the activity of certain enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4) and a drug transporter (OATP1B1). This will be assessed by measuring the area under the plasma concentration-time curve after the probe drugs are taken alone and again after treatment with olutasidenib.
Time frame
Up to 96 hours after each probe drug administration.2
Maximum Plasma Concentration (Cmax) of Probe Drugs
To evaluate how olutasidenib affects the peak levels of probe drugs in the blood after they are taken alone and again after treatment with olutasidenib.
Time frame
Up to 96 hours after each probe drug administration.Secondary outcomes
1
Time to Maximum Plasma Concentration (Tmax) of Probe Drugs
To assess how olutasidenib affects the time required to reach peak plasma concentration for each probe drug.
Time frame
Up to 96 hours after each probe drug administration2
Elimination Half-Life (t½) of Probe Drugs
To evaluate the effect of olutasidenib on the terminal elimination half-life of each probe drug.
Time frame
Up to 96 hours after each probe drug administration3
Percent of Area Under the Curve Extrapolated (%AUCex) of Probe Drugs
To determine the proportion of the AUC that is extrapolated, providing insight into olutasidenib's effect on drug elimination.
Time frame
Up to 96 hours after each probe drug administration4
Elimination Rate Constant (λz) of Probe Drugs
To assess how olutasidenib affects the terminal elimination rate constant of each probe drug.
Time frame
Up to 96 hours after each probe drug administrationSponsors and contacts
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Source ClinicalTrials.gov