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NCT03301181
Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Phase 1 trial testing BGB-3111 (Arm A) in Healthy Volunteers: Asian, Non-Asian in 40 participants. Completed in 13 November 2017.
7 November 2017
Quick facts
| Lead sponsor | BeiGene |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 40 |
| Start date | 18 September 2017 |
| Primary completion | 7 November 2017 |
| Estimated completion | 13 November 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- BGB-3111 (Arm A) — full drug profile →
- Rifampin — full drug profile →
- BGB-3111 (Arm B) — full drug profile →
- Itraconazole — full drug profile →
Conditions studied
- Healthy Volunteers: Asian, Non-Asian — all drugs for Healthy Volunteers: Asian, Non-Asian →
Sponsor
BeiGene — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy Volunteers: Asian, Non-Asian. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comprehensive PBPK model to predict drug interaction potential of Zanubrutinib as a victim or perpetrator.
Wang K, Yao X, Zhang M, Liu D, et al · · 2021 · cited 22× · PMID 33687157 · DOI 10.1002/psp4.12605 -
Population Pharmacokinetic Analysis of the BTK Inhibitor Zanubrutinib in Healthy Volunteers and Patients With B-Cell Malignancies.
Ou YC, Liu L, Tariq B, Wang K, et al · · 2021 · cited 21× · PMID 33306268 · DOI 10.1111/cts.12948
Verify or expand the search:
- PubMed search for NCT03301181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other BeiGene trials
Trials by the same sponsor.
- NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
- NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
- NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB- · Phase 1 · active not recruiting
- NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
- NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · 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 NCT03301181 (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 BeiGene
- Last refreshed: 1 November 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/NCT03301181.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing