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NCT03824678
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
Phase 1 trial testing CC-220 in Hepatic Impairment in 40 participants. Completed in 18 June 2019.
18 June 2019
Quick facts
| Lead sponsor | Celgene |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 13 February 2019 |
| Primary completion | 18 June 2019 |
| Estimated completion | 18 June 2019 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- CC-220 — full drug profile →
Conditions studied
- Hepatic Impairment — all drugs for Hepatic Impairment →
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Celgene — full company profile →
Who can join
Adults 18 to 70, any sex, with Hepatic Impairment or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label study to assess the PK of a single 1-mg oral dose of CC-220 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degree of hepatic impairment will be determined during the Screening period by the subject's score according to Child-Pugh Classification Criteria
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel immunomodulatory drugs and neo-substrates.
Gao S, Wang S, Song Y. · · 2020 · cited 64× · PMID 31938543 · DOI 10.1186/s40364-020-0182-y -
Targeted Protein Degradation: Clinical Advances in the Field of Oncology.
Salama AKAA, Trkulja MV, Casanova E, Uras IZ. · · 2022 · cited 19× · PMID 36499765 · DOI 10.3390/ijms232315440 -
A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects.
Cheng Y, Ye Y, Gaudy A, Ghosh A, et al · · 2023 · cited 3× · PMID 36880014 · DOI 10.2147/cpaa.s397826
Verify or expand the search:
- PubMed search for NCT03824678
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CC-220
Trials testing the same drug.
- NCT04882163 — Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasita · Phase 1, PHASE2 · withdrawn
- NCT04884035 — Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma · Phase 1 · recruiting
- NCT04855136 — Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma · Phase 1, PHASE2 · terminated
- NCT04464798 — A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subje · Phase 1 · terminated
- NCT03310619 — A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies · Phase 1, PHASE2 · completed
Other recruiting trials for Hepatic Impairment
Currently open trials in the same condition.
- NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
- NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
- NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting
Other Celgene trials
Trials by the same sponsor.
- NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
- NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
- NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
- NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
- NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · 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 NCT03824678 (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 Celgene
- Last refreshed: 27 July 2020
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/NCT03824678.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing