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Healthy SubjectsPhase 1NCT05932459

A Study to Evaluate the Bioavailability, Food Effect and Pharmacokinetics of Deuremidevir Hydrobromide for Suspension

A Phase 1 study testing Deuremidevir Hydrobromide for Suspension 100mg, Deuremidevir Hydrobromide for Suspension 300mg and Deuremidevir Hydrobromide for Suspension 25mg in people with Healthy Subjects, run by Vigonvita Life Sciences 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 divided into three parts: bioavailability study (hereinafter referred to as "BA study"), food effect study (hereinafter referred to as "FE study") and pharmacokinetic characteristics study (hereinafter referred to as "PK characteristics study"). A total of 38 subjects are planned to be enrolled. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Deuremidevir Hydrobromide for Suspension 100mg, Deuremidevir Hydrobromide for Suspension 300mg and Deuremidevir Hydrobromide for Suspension 25mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
9 Jul 2023to 4 Sep 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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18 to 60 years old, males or females;
  • Body weight no less than 40 kg, Body Mass Index of 18.5 to 27.0kg/m2;
  • Vital signs examination, physical examination, laboratory examination and electrocardiogram examination results were normal or abnormal without clinical significance;
  • Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;
  • Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.

Who cannot join

  • Subjects with hypersensitivity to deuremidevir hydrobromide for suspension or any of the excipients;
  • Subjects with allergic diseases or allergic constitution;
  • Subjects who are allergic to formula ingredients or lactose intolerant or unable to ingest infant formula (only applicable to FE research);
  • Subjects with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, Hematologic System, metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
  • Subjects with acute upper respiratory tract infection within 2 weeks before screening;
  • Subjects who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (except female physiological blood loss);
Show all 18Show fewer
  • Subjects who have participated in clinical trials of other drugs within 3 months before screening;
  • Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products orally within 2 weeks before screening;
  • Being a drug addict or alcohol addict within one year before screening, being an alcoholic at present or in the past (drinking more than 14 standard units per week, and one standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of strong liquor with 40% alcohol content or 150 mL of wine), or being positive in alcohol breath test;
  • Subjects who smoked more than 5 cigarettes a day within one year before screening;
  • Subjects who can't quit smoking and drinking during the experiment;
  • Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);
  • Abnormal chest X-ray results with clinical significance;
  • Total bilirubin (TBIL) at screening or baseline > upper limit of normal value (ULN); Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 times ULN；;
  • The glomerular filtration rate (EGFR) at screening or baseline is less than 90 ml/min;
  • Abnormal ECG at screening or baseline, single examination of QTcF (after heart rate correction) is >450 ms for male and > 470 ms for female, and/or other abnormalities with clinical significance;
  • Pregnant or lactating woman or male subjects whose spouse has a child care plan within 3 months;
  • The investigator believes that there are other factors that are not suitable for participating in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 201900

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Bioavailability, Food Effect and Pharmacokinetic Characteristics of Oral Deuremidevir Hydrobromide for Suspension in Chinese Healthy Volunteers

This study is divided into three parts: bioavailability study (hereinafter referred to as "BA study"), food effect study (hereinafter referred to as "FE study") and pharmacokinetic characteristics study (hereinafter referred to as "PK characteristics study"). A total of 38 subjects are planned to be enrolled. The three parts of the study can be carried out simultaneously, and there is no order requirement. The subjects will be assigned to one of them according to the enrollment order. Dose selection is 100mg, 300mg and 25mg.

Read the detailed description

BA study plan included 18 subjects, in the form of dry suspension and tablets, with a dose of 100 mg. Subjects were randomly divided into two sequences, TR and RT, with 9 cases in each sequence. They were given once in fasted condition each period, and the dry suspension and tablets were designed in a double crossover way.

12 subjects were enrolled in the FE study plan, and the dose was 300mg in dry suspension. Subjects were randomly divided into two sequences, sequence 1 and sequence 2, with 6 cases in each sequence, and given once per period. Fasting and infant formula milk double crossover were tested in two periods according to the administration sequence.

PK study form is dry suspension, the doses are 25 mg, 100 mg, 300 mg, taken orally once in fasted condition. 8 subjects will be enrolled in the 25mg group. The 100 mg group used the data of 18 subjects with dry suspension in BA study, while the 300 mg group used the fasting condition data of 12 subjects with dry suspension in FE study. The 100 mg and 300 mg groups will not be enrolled separately.

Being tested
Deuremidevir Hydrobromide for Suspension 100mg, Deuremidevir Hydrobromide for Suspension 300mg, Deuremidevir Hydrobromide for Suspension 25mg, Deuremidevir Hydrobromide tablets 100mg
Keywords
VV116-RSV, Bioavailability, Food effect, Pharmacokinetics

What participants receive

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

  • Deuremidevir Hydrobromide for Suspension 100mgDrug

    Also called VV116

    Take it with 240ml water in fasted condition.

  • Deuremidevir Hydrobromide for Suspension 300mgDrug

    Also called VV116

    Take it with water in fasted condition or after taking infant formula.

  • Deuremidevir Hydrobromide for Suspension 25mgDrug

    Also called VV116

    Take it with 240ml water on an empty stomach.

  • Deuremidevir Hydrobromide tablets 100mgDrug

    Also called VV116

    Take it with 240ml water in fasted condition.

Study groups in NCT05932459
Study groupRoleWhat they receive
BA StudyExperimental18 subjects were randomly divided into two sequences, TR and RT, with 9 subjects in each sequence, and were given in fasted condition once per period. In the first period of TR sequence, 100mg Deuremidevir Hydrobromide dry suspension was taken, and in the second period, 100 mg Deuremidevir Hydrobromide tablets were taken. In the first period of RT sequence, 100mg Deuremidevir Hydrobromide tablets were taken, and 100mg Deuremidevir Hydrobromide dry suspension was taken in the second period.
Receives: Drug: Deuremidevir Hydrobromide for Suspension 100mg; Drug: Deuremidevir Hydrobromide tablets 100mg
FE StudyExperimental12 subjects were randomly divided into two sequences, sequence 1 and sequence 2. There were 6 subjects in each sequence, and one dose per period. Sequence 1: Take Deuremidevir Hydrobromide dry suspension in fasted condition in period 1, and take Deuremidevir Hydrobromide dry suspension after taking infant formula for 10 minutes in period 2; Sequence 2: Take Deuremidevir Hydrobromide dry suspension after taking infant formula for 10 minutes in period 1, and take Deuremidevir Hydrobromide dry suspension in fasted condition in period 2.
Receives: Drug: Deuremidevir Hydrobromide for Suspension 300mg
PK StudyExperimentalFasting; PK study form is dry suspension, the doses are 25 mg, 100 mg, 300 mg, taken orally once in fasted condition. 8 subjects in 25 mg group; The 100 mg group used the data of 18 subjects with dry suspension in BA study, while the 300 mg group used the fasting condition data of 12 subjects with dry suspension in FE study.
Receives: Drug: Deuremidevir Hydrobromide for Suspension 100mg; Drug: Deuremidevir Hydrobromide for Suspension 300mg; Drug: Deuremidevir Hydrobromide for Suspension 25mg

What is being measured

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

  1. Cmax

    maximum observed plasma concentration

    Measured: 48 hours after administration

  2. AUC0-t

    area under the plasma concentration time curve from time zero to the last measurable concentration

    Measured: 48 hours after administration

  3. AUC0-∞

    area under the plasma concentration-time curve from time zero to infinity

    Measured: 48 hours after administration

  4. AUC0-24h

    Area under the plasma concentration-time curve from 0 to 24 hours

    Measured: 48 hours after administration

  5. Tmax

    time at which Cmax occurs

    Measured: 48 hours after administration

  6. Tlag

    time lag

    Measured: 48 hours after administration

  7. t1/2z

    half life of elimination

    Measured: 48 hours after administration

  8. CLz/F

    apparent clearance

    Measured: 48 hours after administration

  9. Vz/F

    apparent volume of distribution during the terminal phase

    Measured: 48 hours after administration

Secondary outcomes (1)

  1. AE & SAE

    Adverse event \& serious adverse events

    Measured: From Day1 to Day10 after administration

Timeline

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

  1. First posted6 Jul 2023
  2. Study start9 Jul 2023
  3. Primary completion4 Sep 2023
  4. Study completion4 Sep 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05932459
Sponsor's protocol ID
VV116-RSV-01
Status last verified
Jun 2023
First submitted
21 Jun 2023
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deuremidevir Hydrobromide for Suspension 100mg, Deuremidevir Hydrobromide for Suspension 300mg and Deuremidevir Hydrobromide for Suspension 25mg in people with Healthy Subjects, run by Vigonvita Life Sciences 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 20 Nov 2024. 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?

Cmax (time frame: 48 hours after administration). The study lists 9 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 NCT05932459.

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 20 Nov 2024.

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