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Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers
Phase 1 trial testing Treatment A - 400 mg Fasting in Healthy Volunteers in 24 participants. Completed in 22 May 2019.
| Lead sponsor | Daiichi Sankyo |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 1 April 2019 |
| Primary completion | 8 May 2019 |
| Estimated completion | 22 May 2019 |
| Sites | 1 location across United States |
Daiichi Sankyo — full company profile →
Adults 18 to 60, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Cmax of pexidartinib is calculated for each treatment period
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 4580 | ± 1240 |
| Treatment B | 7090 | ± 1590 |
| Treatment C | 3870 | ± 729 |
Median Tmax of pexidartinib is calculated for each treatment period
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 2.00 | 1.00 – 3.52 |
| Treatment B | 3.50 | 2.50 – 10.00 |
| Treatment C | 3.30 | 2.50 – 4.50 |
Mean AUClast and AUCinf for pexidartinib are calculated for each treatment period
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 64800 | ± 19300 |
| Treatment B | 102000 | ± 26300 |
| Treatment C | 53600 | ± 14200 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 66100 | ± 19900 |
| Treatment B | 104000 | ± 27400 |
| Treatment C | 54600 | ± 15000 |
Mean t1/2 for pexidartinib is calculated for each treatment period
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 24.2 | ± 5.28 |
| Treatment B | 23.1 | ± 4.68 |
| Treatment C | 23.6 | ± 5.04 |
Time frame: Adverse events were collected from study enrollment up to 28 days of administration of the last dose of study treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment A | Treatment B | Treatment C |
|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — |
Data from ClinicalTrials.gov NCT03901313 adverse events section.
All participants in this study are healthy volunteers. Throughout the study, healthy volunteers will have physical exams, electrocardiograms and clinical laboratory tests. The study staff will keep track of symptoms, diet, and what medications they are taking. Each participant will get all three treatments (A, B and C). Only the order in which they receive them will be different. There are six groups based on the order: ABC, ACB, BAC, BCA, CAB, or CBA. Participants have an equal chance of being assigned to any of these groups. For each treatment period, participants will: * fast overnight * receive the assigned treatment with or without food * have a small tube of blood drawn prior to treatment * after dosing, additional blood samples will be drawn at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours * have a break from treatment for 6 days between each treatment period All participants must reside in the clinic for a total of 20 days.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing