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

NCT05932459 | Completed Phase 1

• 1 other identifier: VV116-RSV-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Subjects

Keywords

VV116-RSV; Bioavailability; Food effect; Pharmacokinetics

Outcome Measures

Primary Outcomes (9)

• Cmax

  maximum observed plasma concentration

  48 hours after administration

• AUC0-t

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

  48 hours after administration

• AUC0-∞

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

  48 hours after administration

• AUC0-24h

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

  48 hours after administration

• Tmax

  time at which Cmax occurs

  48 hours after administration

• Tlag

  time lag

  48 hours after administration

• t1/2z

  half life of elimination

  48 hours after administration

• CLz/F

  apparent clearance

  48 hours after administration

• Vz/F

  apparent volume of distribution during the terminal phase

  48 hours after administration

Secondary Outcomes (1)

• AE & SAE

  From Day1 to Day10 after administration

Study Arms (3)

BA Study

EXPERIMENTAL

18 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.

Drug: Deuremidevir Hydrobromide for Suspension 100mg; Drug: Deuremidevir Hydrobromide tablets 100mg

FE Study

EXPERIMENTAL

12 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.

Drug: Deuremidevir Hydrobromide for Suspension 300mg

PK Study

EXPERIMENTAL

Fasting; 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.

Drug: Deuremidevir Hydrobromide for Suspension 100mg; Drug: Deuremidevir Hydrobromide for Suspension 300mg; Drug: Deuremidevir Hydrobromide for Suspension 25mg

Interventions

Deuremidevir Hydrobromide for Suspension 100mg DRUG

Take it with 240ml water in fasted condition.

Also known as: VV116

BA Study; PK Study

Deuremidevir Hydrobromide for Suspension 300mg DRUG

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

Also known as: VV116

FE Study; PK Study

Deuremidevir Hydrobromide for Suspension 25mg DRUG

Take it with 240ml water on an empty stomach.

Also known as: VV116

PK Study

Deuremidevir Hydrobromide tablets 100mg DRUG

Take it with 240ml water in fasted condition.

Also known as: VV116

BA Study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 201900, China

Location

MeSH Terms

Interventions

Suspensions; GS-621763

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jing Zhang

  Hushan Hospital of the Fudan university

  PRINCIPAL INVESTIGATOR

• Xiaojie Wu

  Hushan Hospital of the Fudan university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 6, 2023
• Study Start: July 9, 2023
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: November 20, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)