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NCT04309526
Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects
Phase 1 trial testing NCO-48 Fumarate in Hepatitis B in 48 participants. Completed in 13 October 2020.
3 August 2020
Quick facts
| Lead sponsor | Nucorion Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 18 March 2020 |
| Primary completion | 3 August 2020 |
| Estimated completion | 13 October 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NCO-48 Fumarate — full drug profile →
- Placebo
Conditions studied
- Hepatitis B — all drugs for Hepatitis B →
Sponsor
Nucorion Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 21 to 65, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its active metabolite, tenofovir (TFV), in healthy subjects following single oral doses and to evaluate the effect of food on the PK of a 30 mg dose of NCO-48 Fumarate in healthy subjects.
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 NCT04309526
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Nucorion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT04629976 — Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic Hepatitis B · Phase 1 · completed
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 NCT04309526 (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 Nucorion Pharmaceuticals, Inc.
- Last refreshed: 3 November 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/NCT04309526.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing