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Healthy VolunteersPhase 1NCT05789342

A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers

A Phase 1 study testing GP681, Rosuvastatin and Digoxin in people with Healthy Volunteers, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a four-part, single-center, Open label phase I clinical study to characterize the DDIs potential of GP681 With Rosuvastatin, Digoxin, Itraconazole or Oseltamivir in Chinese healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
GP681, Rosuvastatin and Digoxin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
15 Feb 2023to 31 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males or females between the ages of 18 and 55 years, inclusive;
  • Body weight ≥50.0 kg for males, ≥45kg for females, and body mass index (BMI) between19-26 kg/m^2(inclusive);
  • Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant;
  • Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 3 months after the final dose of study drug
  • Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

Who cannot join

  • History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to GP681 or any of the ingredients of its formulation or similar drugs. Those who cannot follow a uniform diet for special dietary requirements.
  • Subjects with swallowing difficulties, or have diseases such as hemorrhoids, perianal diseases with regular/bleeding in the stool, habitual constipation or diarrhea, irritable bowel syndrome and inflammatory bowel diseases, affecting drug absorption, distribution, metabolism, excretion or the efficacy and safety of the drug.
  • History of gastrointestinal ulcer or bleeding; Or history of any clinically significant diseases or diseases which may affect the result of this study, such as gastrointestinal, circulatory, respiratory, endocrine, neurological, urinary, hematological, immunological, psychiatric and metabolic diseases;
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes ventricular tachycardia, ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history;
  • Patients who have undergone surgery within 6 months before the screening period, or who have undergone major surgery within 28 days, or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury;
  • Pregnant or lactating female subjects, female subjects with childbearing potential and positive pregnancy test at baseline.
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  • History of receiving a live vaccine within 1 month prior to the screening, or is expected to receive a live vaccine during the study.
  • Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
  • Received any drugs that inhibit or induce the CYP450 enzyme (i.e., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors- SSRI-antidepressant, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) 30 days prior to screening period;
  • Received any drugs (including Chinese herbal medicine, vitamins and supplements) within 14 days prior to dosing, or participation in another clinical trial within 3 months before dosing.
  • Those who have lost blood or donated up to 200 mL within 3 months before dosing, or those who plan to donate blood within 1 month after the end of this study;
  • Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
  • Average weekly intake of alcohol is more than 21 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) within the 3 months prior to dosing, or a positive ethanol breath test at screening;
  • Substance abuse or use of soft drugs (e.g., marijuana) or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.); Or screening for positive urine drug abuse (drug) tests;
  • Habitual or excessive consumption (more than 8 cups, 1cup=250mL) of grapefruit juice, tea, coffee and/or caffeinated beverages;
  • Subjects who are intolerant to venipuncture or have a history of fainting blood or acupuncture
  • Inability to take normal hospital diet;
  • Subjects with poor compliance, or not suitable for this study as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • China-Japan Friendship Hospital

    Beijing

Other trials in China

About this study

Official title: A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-drug Interactions (DDIs) Between GP681 and Rosuvastatin/Digoxin/Itraconazole/Oseltamivir in Chinese Healthy Volunteers

This study is a four-part, single-center, Open label phase I clinical study to characterize the DDIs potential of GP681 With Rosuvastatin, Digoxin, Itraconazole or Oseltamivir in Chinese healthy volunteers. This study also aims to evaluate the safety and tolerability of GP681 in the presence of Rosuvastatin, Digoxin, Itraconazole, or Oseltamivir.

Read the detailed description

GP681 is a potent polymerase acidic (PA) protein endonuclease inhibitor. This study will be run in four parts to characterize the DDIs potential of GP681 with the expected concomitant drugs (Rosuvastatin, Digoxin, Itraconazole, Oseltamivir) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period, and a follow-up telephone call for safety.

Being tested
GP681, Rosuvastatin, Digoxin, Itraconazole, Oseltamivir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GP681Drug

    GP681, tablet, oral

  • RosuvastatinDrug

    Rosuvastatin, tablet, oral

  • DigoxinDrug

    Digoxin, tablet, oral

  • ItraconazoleDrug

    Itraconazole, capsule, oral

  • OseltamivirDrug

    Oseltamivir, capsule, oral

Study groups in NCT05789342
Study groupRoleWhat they receive
The DDI of GP681 and Rosuvastatin Calcium TabletsExperimentalSubjects will receive a single dose of Rosuvastatin Calcium 10 mg on Day 1, then take a single doses of 40mg GP681, 10mg Rosuvastatin Calcium on Day 8.
Receives: Drug: GP681; Drug: Rosuvastatin
The DDI of GP681 and Digoxin TabletsExperimentalSubjects will receive a single dose of Digoxin 0.25 mg on Day 1, then take a single doses of 40mg GP681, 0.25mg Digoxin on Day 15.
Receives: Drug: GP681; Drug: Digoxin
The DDI of GP681 and Itraconazole CapsulesExperimentalSubjects will receive a single dose of GP681 20mg on Day 1, then take Itraconazole 200 mg twice-daily on Day 22 and 200 mg once-daily on Day 23 through Day 36, and took a single dose of GP681 20 mg on Day 26.
Receives: Drug: GP681; Drug: Itraconazole
The DDI of GP681 and Oseltamivir CapsulesExperimentalSubjects will receive all three treatments in a crossover fashion according to the randomized sequence. The treatments were as follows: single oral administration of GP681 at 40 mg on day 1 in the fasted state; single oral administration of oseltamivir at 75 mg on day 1 and day 5in the fasted state, followed by repeated twice-daily administration of oseltamivir at 75 mg until day 5 after each meal; co-administration of GP681 at 40 mg and oseltamivir at 75 mg simultaneously on day 1 in the fasted state, followed by repeated twice-daily administration of oseltamivir at 75 mg until day5 after each meal. There was an at least 21-day washout interval between each treatment.
Receives: Drug: GP681; Drug: Oseltamivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part one: Peak plasma concentration (Cmax) of Rosuvastatin

    Measured: Day 1 to Day 4, and Day 8 to Day 11

  2. Part one: Area under the plasma concentration versus time curve (AUC) of Rosuvastatin

    Measured: Day 1 to Day 4, and Day 8 to Day 11

  3. Part two: Peak plasma concentration (Cmax) of Digoxin

    Measured: Day 1 to Day8, and Day 15 to Day 22

  4. Part two: Area under the plasma concentration versus time curve (AUC) of Digoxin

    Measured: Day 1 to Day 8, and Day 15 to Day 22

  5. Part three: Peak plasma concentration (Cmax) of GP681

    Measured: Day 1 to Day12, and Day26 to Day 37

  6. Part three: Area under the plasma concentration versus time curve (AUC) of GP681

    Measured: Day 1 to Day 12, and Day26 to Day 37

  7. Part Four: Peak plasma concentration (Cmax) of GP681

    Measured: 264 hours after GP681 administration

  8. Part Four: Area under the plasma concentration versus time curve (AUC) of GP681

    Measured: 264 hours after GP681 administration

  9. Part Four: Peak plasma concentration (Cmax) of Oseltamivir

    Measured: 12 hours after Oseltamivir administration

  10. Part Four: Area under the plasma concentration versus time curve (AUC) of Oseltamivir

    Measured: 12 hours after Oseltamivir administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2023
  2. Study start15 Feb 2023
  3. Primary completion11 Sep 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05789342
Sponsor's protocol ID
GP681-202202
Status last verified
Nov 2023
First submitted
21 Feb 2023
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Han M, Cui G, Zhao Y, Zuo X, Wang X, Zhang X, Mi N, Jin J, Xiao C, Wang J, Wu W, Li Y, Li J. Evaluation of drug-drug interaction between Suraxavir Marboxil (GP681) and itraconazole, and assessment of the impact of gene polymorphism. Front Pharmacol. 2025 Apr 11;15:1505557. doi: 10.3389/fphar.2024.1505557. eCollection 2024.

    PubMed 40291342

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GP681, Rosuvastatin and Digoxin in people with Healthy Volunteers, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part one: Peak plasma concentration (Cmax) of Rosuvastatin (time frame: Day 1 to Day 4, and Day 8 to Day 11). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05789342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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