AzTrials
AzTrials

HealthyPhase 1NCT04358523

A Study of the Relative Bioavailability of ASC18 Tablets vs Reference Tablets in Healthy Volunteers

A Phase 1 study testing ASC18 and ravidasvir and sofosbuvir in people with Healthy, run by Ascletis Pharmaceuticals 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
Search all trials

Trial summary

The objective of this study is to evaluate potential drug interaction between RDV and SOF in ASC18 tablets (RDV/SOF compound tablets) and the influence of food effect on the pharmacokinetics of ASC18 tablets were evaluated in healthy subjects -and compare the pharmacokinetic parameters of ASC18 tablets（ravidasvir and… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ASC18 and ravidasvir and sofosbuvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
20 Mar 2020to 15 Dec 2020
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-45 (including 18 and 45 years old), both male and female.
  • Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI between 19-24 kg / m2 (including boundary value).
  • According to the medical history, hearing examination, physical examination, vital signs, laboratory examination and 12 lead electrocardiogram (ECG) examination, the general health condition is good, and there is no clinically significant abnormality in each index.
  • There was no family planning in the past half a year, and they were willing to take effective contraceptive measures within half a year after the last administration.
  • Non pregnant or lactating women.
  • Serum creatinine measured during screening evaluation and creatinine clearance rate (CrCl) from actual body weight (greater than or equal to 80 ml / min (using Cockcroft Gault method)).
  • Voluntary signing of informed consent.

Who cannot join

  • (1) Have or are currently suffering from any serious clinical disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease (such as anemia, hearing impairment, hyperthyroidism, etc.) that can interfere with the test results.
  • Family history of malignant tumor, history of epilepsy, history of tuberculosis or contact history of tuberculosis patients.
  • Has had gastrointestinal surgery, vagotomy, enterotomy, or any surgery (other than herniorrhaphy, appendectomy) that may interfere with gastrointestinal peristalsis, pH, or absorption.
  • Those with drug allergy constitution, including those with drug or food allergy history.
  • Any prescription medicine, over-the-counter medicine, any vitamin product or herbal medicine, such as St. John's wort, echinacea, silymarin (i.e. silymarin), Xiaochaihu Decoction, was used within 14 days before the first administration. (6) Smokers or those who smoked more than 5 cigarettes per day in 3 months before the trial.
  • Alcoholics or regular drinkers within 6 months before the test, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits with 40% alcohol or 150 ml of wine).
Show all 14Show fewer
  • Those who drink too much tea, coffee or caffeinated beverage (more than 8 cups, 1 cup = 250 ml) every day within 3 months before the first administration. (9) 48 hours before taking the first research, any food or drink containing caffeine or coffee (rich in tea, chocolate, etc.) or foods rich in xanthine (e.g. sardine, animal liver, etc.) or beverage were consumed or planned.
  • Blood donation or blood loss of more than 400ml occurred within 3 months before the first administration.
  • Those who had participated in other clinical trials and received study drug treatment within 3 months before the first administration.
  • Those who have used the oral contraceptive within 30 days before the first administration, or those who have used the long-acting estrogen or progesterone injection or implant within 6 months before the first administration.
  • There were unprotected actors (women) within 14 days before the first administration.
  • Those who have special requirements for diet and cannot follow the unified diet.
  • Subjects who could not tolerate the high fat and high calorie breakfast (this article only applies to the subjects who participated in the PK effect test of food). (16) Irregular defecation within 7 days before the first administration.
  • Unqualified alcohol test or positive drug abuse screening. (18) HBsAg, HCV AB, HIV AB and Treponema pallidum were positive. (19) In addition to the above, the researcher judged that it was not suitable to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

Other trials in China

About this study

Official title: Drug Interaction Between RDV and SOF in ASC18 Tablets (RDV/SOF Compound Tablets) and the Influence of Food Effect on the Pharmacokinetics of ASC18 Tablets Were Evaluated in Healthy Subjects. Comparison of the Pharmacokinetic Parameters of ASC18 Tablets（Ravidasvir and Sofosbuvir Fixed Dose Combination）With Reference Tablets (Ravidasvir Sofosbuvir) in Healthy Subjects After Single and Multiple Oral Dosing

The objective of this study is to evaluate potential drug interaction between RDV and SOF in ASC18 tablets (RDV/SOF compound tablets) and the influence of food effect on the pharmacokinetics of ASC18 tablets were evaluated in healthy subjects -and compare the pharmacokinetic parameters of ASC18 tablets（ravidasvir and sofosbuvir fixed dose combination）with ravidasvir tablets and sofosbuvir tablets in healthy subjects after single and multiple oral dosing.

Read the detailed description

This randomized, open-label, crossover study will evaluate the relative bioavailability of ASC18 (ravidasvir and sofosbuvir fixed dose combination) tablets as compared to ad hoc combination of reference tablets of ravidasvir and sofosbuvir in healthy volunteers. Subjects will be randomized to 1 of 2 treatment sequences to receive multiple oral doses of either ASC18 tablets (ravidasvir and sofosbuvir fixed Dose Combination) or ravidasvir and sofosbuvir as separate tablets. In the crossover design, subjects will participate in 2 study periods with at least a 14-day washout between periods.

Conditions
Healthy
Being tested
ASC18, ravidasvir and sofosbuvir

What participants receive

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

  • ASC18Drug

    ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg

  • ravidasvir and sofosbuvirDrug

    RDV 200 mg and SOF 400 mg

  • ASC18Drug

    ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg

Study groups in NCT04358523
Study groupRoleWhat they receive
ASC18 (D1,D4-13）;RDV + SOF(D27,D30-39)ExperimentalASC18 one tablet (200mg RDV+400mg SOF / tablet) at a time, once per day, day 1 and day 4 to 13. RDV one tablet (200mg / tablet) SOF one tablet (400mg/tablet)at a time, once per day, day 27 and day 30 to 39.
Receives: Drug: ASC18; Drug: ravidasvir and sofosbuvir
RDV + SOF (D1,D4-13）;ASC18(D27,D30-39)ExperimentalRDV one tablet (200mg / tablet) SOF one tablet (400mg/tablet)at a time, once per day, day 1 and day 4 to 13. ASC18 one tablet (200mg RDV+400mg SOF / tablet) at a time, once per day, day 27 and day 30 to 39.
Receives: Drug: ravidasvir and sofosbuvir; Drug: ASC18

What is being measured

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

  1. Evaluation of the safety and tolerability of ASC18 in healthy volunteers: number of Adverse Events

    Evaluate number of Adverse Events as a measure of safety and tolerability of ASC18.

    Measured: Up to 93 days

Secondary outcomes (6)

  1. Cmax of ASC18

    Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers.

    Measured: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days.

  2. Tmax of ASC18

    Evaluate the Time to reach the maximum plasma concentration after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers.

    Measured: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days

  3. AUC of ASC18

    Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers.

    Measured: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days

  4. t1/2 of ASC18

    Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers volunteers.

    Measured: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days

  5. CL/F of ASC18

    Evaluate the Apparent Systemic Clearance after single oral dose of ASC18 administered to Chinese healthy volunteers.

    Measured: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days

  6. Vd/F of ASC18

    Evaluate the Apparent Volume of Distribution after single oral dose of ASC18 administered to Chinese healthy volunteers.

    Measured: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days

Timeline

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

  1. First posted24 Apr 2020
  2. Study start20 Mar 2020
  3. Primary completion15 Dec 2020
  4. Study completion15 Dec 2020

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
Crossover
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04358523
Sponsor's protocol ID
ASC-ASC18-I-CTP-01
Status last verified
Mar 2020
First submitted
21 Apr 2020
Last updated
11 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASC18 and ravidasvir and sofosbuvir in people with Healthy, run by Ascletis Pharmaceuticals 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 7 inclusion and 14 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 11 Jan 2021. 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?

Evaluation of the safety and tolerability of ASC18 in healthy volunteers: number of Adverse Events (time frame: Up to 93 days). 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 NCT04358523.

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 11 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in