Idiopathic Pulmonary FibrosisPhase 1NCT03092102
The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects
A Phase 1 study testing HEC585 in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in United States.
Trial summary
The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 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?
- HEC585
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2017to 25 Feb 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 sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening and/or Check-in as assessed by the Investigator (or designee).
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
- Able to comprehend and willing to sign an informed consent form (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).
- 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 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), or a positive alcohol breath test at Check-in.
- Positive urine drugs of abuse screen including cotinine at Screening or Check-in.
Show all 19Show fewer
- Positive hepatitis B surface antigen, hepatitis C virus antibody and/or positive human immunodeficiency virus (HIV) test (Appendix 3).
- Absolute lymphocyte count below the lower limit of normal which can be confirmed by repeat.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to Check-in.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee). Strong CYP3A inhibitors and inducers should be avoided.
- Use or intend to use any prescription medications/products, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
- Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges within 7 days prior to Check-in, consumption of caffeine-containing foods and beverages within 72 hours prior to Check-in, or consumption of alcohol within 48 hours prior to Check-in.
- 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, 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.
Madison, Wisconsin, 35756
About this study
Official title: A Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects
The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 in Healthy Male and Female Subjects
Read the detailed description
This will be a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.
Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Up to 48 subjects will be studied in up to 6 groups (Groups A1 to A6), with each group consisting of 8 subjects. Each subject will participate in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours postdose), except for Group A3, which will participate in a second treatment period for a food effect evaluation. Each subject in Group A3 will participate in 2 treatment periods separated by a minimum of 7 days. Dosing of subjects in the fed state in Group A3 can commence after review of the safety data from Group A4.
Part B will comprise a multiple-dose, sequential-group study. Up to 36 subjects will be studied in up to 3 groups (Groups B1 to B3), with each group consisting of 12 subjects. Part B of the study may start after completion of Group A5, at a dose equal or less than given in Groups A1 to A3.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- HEC585
- 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.
HEC585Drug
HEC585, a pyrimidone compound, is structurally related to pirfenidone, a pyridine compound.
| Study group | Role | What they receive |
|---|---|---|
| A single dose HEC585（A1） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| A single dose HEC585（A2） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| A single dose HEC585/FE（A3） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule
Treatment Period 1：No food prior to dosing；Treatment Period 2：High-fat meal prior to dosing Receives: Drug: HEC585 |
| A single dose HEC585（A4） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| A single dose HEC585（A5） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| A single dose HEC585（A6） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| A single dose HEC585（A7） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| A single dose HEC585（A8） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| Multiple doses HEC585（B1） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| Multiple doses HEC585（B2） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| Multiple doses HEC585（B3） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| Multiple doses HEC585（B4） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| Multiple doses HEC585（B5） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
| Multiple doses HEC585（B6） | Experimental | Drug: HEC585 Capsule
Drug: HEC585-matching placebo Capsule Receives: Drug: HEC585 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC585
Measured: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
(AUC0-∞）
area under the plasma concentration-time curve (AUC) from time zero to infinity
Measured: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h
tmax
time of the maximum observed plasma concentration
Measured: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
Vz/F
apparent volume of distribution
Measured: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h
t½
apparent terminal elimination half-life
Measured: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
CL/F
apparent oral clearance
Measured: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
Secondary outcomes (1)
Adverse event
To assess the safety and tolerability of 7 days therapy.
Measured: From baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start20 May 2017
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092102
- Sponsor's protocol ID
- PCD-DHEC585-16-001
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2017
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03092102
- Acronym / sponsor ID
- PCD-DHEC585-16-001
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2017 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 in Healthy Male and Female Subjects
Detailed description
This will be a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.
Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Up to 48 subjects will be studied in up to 6 groups (Groups A1 to A6), with each group consisting of 8 subjects. Each subject will participate in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours postdose), except for Group A3, which will participate in a second treatment period for a food effect evaluation. Each subject in Group A3 will participate in 2 treatment periods separated by a minimum of 7 days. Dosing of subjects in the fed state in Group A3 can commence after review of the safety data from Group A4.
Part B will comprise a multiple-dose, sequential-group study. Up to 36 subjects will be studied in up to 3 groups (Groups B1 to B3), with each group consisting of 12 subjects. Part B of the study may start after completion of Group A5, at a dose equal or less than given in Groups A1 to A3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| A single dose HEC585（A1） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A2） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585/FE（A3） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Treatment Period 1：No food prior to dosing；Treatment Period 2：High-fat meal prior to dosing |
| A single dose HEC585（A4） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A5） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A6） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A7） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A8） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B1） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B2） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B3） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B4） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B5） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B6） | Experimental | Drug: HEC585Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening and/or Check-in as assessed by the Investigator (or designee).
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Key exclusion criteria (19 listed)
- 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).
- 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 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), or a positive alcohol breath test at Check-in.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC585HEC585, a pyrimidone compound, is structurally related to pirfenidone, a pyridine compound. | Drug | A single dose HEC585/FE（A3）, A single dose HEC585（A1）, A single dose HEC585（A2）, A single dose HEC585（A4）, A single dose HEC585（A5）, A single dose HEC585（A6）, A single dose HEC585（A7）, A single dose HEC585（A8）, Multiple doses HEC585（B1）, Multiple doses HEC585（B2）, Multiple doses HEC585（B3）, Multiple doses HEC585（B4）, Multiple doses HEC585（B5）, Multiple doses HEC585（B6） |
Primary outcome
Cmax
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
Geometric Mean of Maximum Observed Plasma Concentration of HEC585
(AUC0-∞）
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h
area under the plasma concentration-time curve (AUC) from time zero to infinity
tmax
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
time of the maximum observed plasma concentration
Vz/F
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h
apparent volume of distribution
t½
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
apparent terminal elimination half-life
CL/F
Time frame: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h
apparent oral clearance
1 secondary outcome
Adverse event
Time frame: From baseline to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEC585 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 5 inclusion and 19 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 27 Jul 2020. 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. 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: Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2020.