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NCT05988021
A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
Phase 1 trial testing CCX168 in Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis in 16 participants. Completed in 25 May 2016.
9 February 2016
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 16 |
| Start date | 3 December 2015 |
| Primary completion | 9 February 2016 |
| Estimated completion | 25 May 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CCX168 (CCX168) — full drug profile →
Conditions studied
- Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis — all drugs for Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis →
Sponsor
Amgen — full company profile →
Who can join
Adults 18 to 55, any sex, with Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy volunteers.
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 NCT05988021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CCX168
Trials testing the same drug.
- NCT05988008 — A Study of CCX168 in Japanese and Caucasian Healthy Adult Males · Phase 1 · completed
- NCT06004947 — A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications · Phase 1 · completed
- NCT02464891 — Complement Inhibition in aHUS Dialysis Patients · Phase 2 · terminated
- NCT02384317 — Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade · Phase 2 · completed
- NCT05984251 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants · Phase 1 · completed
Other Amgen trials
Trials by the same sponsor.
- NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
- NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
- NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
- NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
- NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · 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 NCT05988021 (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 Amgen
- Last refreshed: 14 August 2023
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/NCT05988021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing