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NCT05160389
A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200
Phase 1 trial testing PBI-200 in Food Effect in Healthy Volunteers in 16 participants. Completed in 6 January 2022.
6 January 2022
Quick facts
| Lead sponsor | Pyramid Biosciences |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 17 November 2021 |
| Primary completion | 6 January 2022 |
| Estimated completion | 6 January 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PBI-200
Conditions studied
- Food Effect in Healthy Volunteers — all drugs for Food Effect in Healthy Volunteers →
Sponsor
Pyramid Biosciences — full company profile →
Who can join
Adults 18 to 55, any sex, with Food Effect in Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05160389
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PBI-200
Trials testing the same drug.
- NCT04901806 — Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors · Phase 1 · terminated
Other recruiting trials for Food Effect in Healthy Volunteers
Currently open trials in the same condition.
- NCT07060209 — Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults · Phase 1 · recruiting
Other Pyramid Biosciences trials
Trials by the same sponsor.
- NCT05692570 — A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers · Phase 1 · completed
- NCT05690932 — A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers · Phase 1 · completed
- NCT05238337 — A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 · Phase 1 · completed
- NCT05514353 — A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream · Phase 1 · completed
- NCT04901806 — Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors · Phase 1 · terminated
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 NCT05160389 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pyramid Biosciences
- Last refreshed: 27 January 2022
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/NCT05160389.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing