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NCT03301207
A Study to Evaluate the Effect of Ibrutinib on the Pharmacokinetics of Oral Contraceptives, CYP2B6, and CYP3A4 Substrates in Female Participants With B Cell Malignancy
Phase 1 trial testing Ibrutinib in Leukemia, Lymphocytic, Chronic, B-Cell in 25 participants. Completed in 4 December 2018.
17 July 2018
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 25 |
| Start date | 20 October 2017 |
| Primary completion | 17 July 2018 |
| Estimated completion | 4 December 2018 |
| Sites | 4 locations across Spain, Poland |
Drugs / interventions tested
- Ibrutinib (ibrutinib) — full drug profile →
- OC: Ethinylestradiol (EE) 30 mcg and Levonorgestrel (LN) 150 mcg — full drug profile →
- Bupropion (bupropion) — full drug profile →
- Midazolam (midazolam) — full drug profile →
Conditions studied
- Leukemia, Lymphocytic, Chronic, B-Cell — all drugs for Leukemia, Lymphocytic, Chronic, B-Cell →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
18 and older, female only, with Leukemia, Lymphocytic, Chronic, B-Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main purpose of this study is to evaluate the effects of repeat dosing of ibrutinib on the single-dose pharmacokinetics (PK) of oral contraceptives (OC - ethinylestradiol \[EE\] and levonorgestrel \[LN\]), the cytochrome P450 (CYP)2B6 probe bupropion and the CYP3A4 probe midazolam; and to evaluate the effects of single-dose ibrutinib on the single-dose PK of the CYP3A4 probe midazolam in female participants with B cell malignancy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ibrutinib does not have clinically relevant interactions with oral contraceptives or substrates of CYP3A and CYP2B6.
de Jong J, Mitselos A, Jurczak W, Cordoba R, et al · · 2020 · cited 3× · PMID 32945596 · DOI 10.1002/prp2.649
Verify or expand the search:
- PubMed search for NCT03301207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting
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Currently open trials in the same condition.
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Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
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- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03301207 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 5 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03301207.
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