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Idiopathic Pulmonary FibrosisPhase 1NCT03502902

The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects

A Phase 1 study testing HEC 68498 in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in United States.

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

A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
HEC 68498
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteUnited States
Study dates
26 Apr 2018to 15 Mar 2019
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

  • Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
  • Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
  • In good health, determined by no clinically significant findings from medical history,physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
  • Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Section 6.6.
  • Where doses exceed 10 mg or where the maximum systemic exposure for any individual subject is predicted to exceed that at the NOAEL of the male rat, male subjects must be sterile. For the purposes of this study, sterile male subjects will include those who have had a vasectomy performed at least 90 days prior to the screening visit and have documentation of azoospermia. Virile male subjects will include all males that do not meet the definition of sterile.
  • Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Who cannot join

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  • Fasting blood glucose >110 mg/dL (confirmed with repeat testing).
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  • History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
  • History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
  • Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
Show all 17Show fewer
  • Positive urine drug screen (including cotinine) at Screening or Check-in, or positive alcohol breath test at Check-in.
  • Positive hepatitis panel and/or positive human immunodeficiency virus test.
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing.
  • Use or intend to use any prescription or nonprescription medications/products, including St. John抯 wort, vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing,unless deemed acceptable by the Investigator (or designee).
  • Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
  • Unwilling or unable to abide by the dietary and exercise restrictions .
  • Receipt of blood products within 2 months prior to Check-in.
  • Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  • Poor peripheral venous access.
  • Have previously completed or withdrawn from this study or any other study investigating HEC68498, and have previously received the investigational product.
  • Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit, Inc.

    Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects

A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects

Read the detailed description

Single-dose, sequential-group design incorporating a food-effect evaluation. Each subject will participate in 1 treatment period, except for Group 5, where each subject will participate in 2 treatment periods. In each group, 6 subjects will receive HEC68498 and 2 subjects will receive placebo. Subjects in Group 5 will receive the same dose level of HEC68498 (or placebo) in both treatment periods. All doses will be administered either after an overnight fast of at least 8 hours or, for subjects in the food-effect evaluation, approximately 30 minutes after starting a standard high-fat breakfast. The first 2 subjects in each group will be dosed (1 subject receiving HEC68498 and 1 subject receiving placebo) 48 hours prior to the remainder of the subjects. There will be a minimum of 7 days between dose escalations. The washout period for subjects in Group 5 will be determined following review of available PK data.

Being tested
HEC 68498, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

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

  • HEC 68498Drug

    HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.

  • PlaceboDrug

    Placebo

Study groups in NCT03502902
Study groupRoleWhat they receive
HEC68498Experimentaladministered once on first day in each Treatment Period， HEC68498 VS placebo 3:1 ratio
Receives: Drug: HEC 68498
placeboPlacebo comparatoradministered once on first day in each Treatment Period
Receives: Drug: Placebo

What is being measured

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

  1. Adverse event

    To assess the safety and tolerability of single dose administered

    Measured: up to 4 weeks

Secondary outcomes (6)

  1. AUC0-∞

    area under the concentration versus time curve (AUC) from time zero to infinity

    Measured: up to one week

  2. AUC0-t

    AUC from time zero to the time of the last quantifiable concentration time zero to the time of the last quantifiable concentration

    Measured: up to one week

  3. Cmax

    maximum observed plasma concentration

    Measured: up to one week

  4. tmax

    time of the maximum observed plasma concentration

    Measured: up to one week

  5. t½

    apparent terminal elimination half-life

    Measured: up to one week

  6. Vz/F

    apparent volume of distribution

    Measured: up to one week

Timeline

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

  1. First posted19 Apr 2018
  2. Study start26 Apr 2018
  3. Primary completion15 Mar 2019
  4. Study completion15 Mar 2019

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03502902
Sponsor's protocol ID
PCD-DHEC68498-17-001
Status last verified
May 2021
First submitted
10 Apr 2018
Last updated
7 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HEC 68498 in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in United States.

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 6 inclusion and 17 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 7 May 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 United States. 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. Some participants in this study may receive a placebo. 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?

Adverse event (time frame: up to 4 weeks). 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 NCT03502902.

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 7 May 2021.

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