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NCT06087055
Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants
Phase 1 trial testing GST-HG171/Ritonavir in Healthy Participant in 12 participants. Completed in 7 August 2023.
5 June 2023
Quick facts
| Lead sponsor | Fujian Akeylink Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 12 |
| Start date | 12 May 2023 |
| Primary completion | 5 June 2023 |
| Estimated completion | 7 August 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- GST-HG171/Ritonavir — full drug profile →
- Itraconazole — full drug profile →
- GST-HG171/Ritonavir — full drug profile →
Conditions studied
- Healthy Participant — all drugs for Healthy Participant →
Sponsor
Fujian Akeylink Biotechnology Co., Ltd. — full company profile →
Who can join
Adults 18 to 50, any sex, with Healthy Participant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Inhibitors of SARS-CoV-2 Main Protease (Mpro) as Anti-Coronavirus Agents.
Zagórska A, Czopek A, Fryc M, Jończyk J. · · 2024 · cited 19× · PMID 39062511 · DOI 10.3390/biom14070797 -
Pharmacokinetic drug-drug interaction between the COVID-19 3CL protease inhibitor GST-HG171 and itraconazole in healthy subjects.
Li X, Li B, Wang M, Wang J, et al · · 2026 · PMID 42112804 · DOI 10.1128/aac.00285-26
Verify or expand the search:
- PubMed search for NCT06087055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GST-HG171/Ritonavir
Trials testing the same drug.
- NCT05656443 — Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19 · Phase 2, PHASE3 · completed
Other recruiting trials for Healthy Participant
Currently open trials in the same condition.
- NCT07455240 — A Study to Learn About How the Body Processes the Study Medicine Called PF-07328948 in Healthy Chinese Adults · Phase 1 · active not recruiting
- NCT07153159 — A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding · Phase 1 · recruiting
Other Fujian Akeylink Biotechnology Co., Ltd. trials
Trials by the same sponsor.
- NCT07090759 — To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) · Phase 3 · recruiting
- NCT06263959 — A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 · Phase 2 · recruiting
- NCT06084507 — Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants · Phase 1 · unknown
- NCT06106126 — Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal Function · NA · unknown
- NCT05637541 — Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets · Phase 2 · 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 NCT06087055 (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 Fujian Akeylink Biotechnology Co., Ltd.
- Last refreshed: 17 October 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/NCT06087055.
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