Idiopathic Pulmonary FibrosisPhase 1NCT05383131
To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers
A Phase 1 study testing HEC585, Pirfenidone and Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or Nintedanib in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- HEC585, Pirfenidone and Nintedanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2021to 30 Nov 2021
- 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
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- Subjects aged between 18 and 45 (both inclusive) years old. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female in the first part of the trial) and body mass index ≥19 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram.
Who cannot join
- Subjects with a positive serology for HIV antibodies, HBsAg, HCV antibodies and/or TP antibodies at screening.
- Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, reproductive system; and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions that are not suitable for clinical trial participation.
- Patients with photosensitivity and/or other skin diseases. Bleeding or thrombosis risk. Allergic. Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test. History of alcoholism or drink regularly within 3 months prior to the study. Positive for urine cotinine or smoked within 1 month before administration of study drug in the first part，regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug in the second part.
- Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
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- Subjects who plan to receive or have had organ transplants. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
- Subjects who participated in another clinical trial and have taken other study drugs within 3 months prior to initial dosing.
- Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open Label Study to Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers
An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or Nintedanib in healthy volunteers
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- HEC585, Pirfenidone, Nintedanib
- 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
Mulltiple doses of HEC585 for up to 10 days
PirfenidoneDrug
Mulltiple doses of Pirfenidone for up to 3 days
NintedanibDrug
Mulltiple doses of Nintedanib for up to 7 days
| Study group | Role | What they receive |
|---|---|---|
| HEC585 and Pirfenidone | Experimental | period 1 - Pirfenidone X mg, TID; period 2 - HEC585 X mg, QD; period 3 - Pirfenidone X mg, TID + HEC585 X mg, QD. Receives: Drug: HEC585; Drug: Pirfenidone |
| HEC585 and Nintedanib | Experimental | period 1 - Nintedanib X mg, BID; period 2 - HEC585 X mg, QD; period 3 - Nintedanib X mg, BID + HEC585 X mg, QD. Receives: Drug: HEC585; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of HEC585 and Pirfenidone
Measured: 0~96 hour
AUC of HEC585 and Pirfenidone
Measured: 0~96 hour
Cmax of HEC585 and Nintedanib
Measured: 0~96 hour
AUC of HEC585 and Nintedanib
Measured: 0~96 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start23 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT05383131
- Sponsor's protocol ID
- HEC585-P-04 / CRC-C2032
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label Study to Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05383131
- Acronym / sponsor ID
- HEC585-P-04 / CRC-C2032
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 19 May 2022 (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.
An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or Nintedanib in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEC585 and Pirfenidone | Experimental | Drug: HEC585, Drug: Pirfenidoneperiod 1 - Pirfenidone X mg, TID; period 2 - HEC585 X mg, QD; period 3 - Pirfenidone X mg, TID + HEC585 X mg, QD. |
| HEC585 and Nintedanib | Experimental | Drug: HEC585, Drug: Nintedanibperiod 1 - Nintedanib X mg, BID; period 2 - HEC585 X mg, QD; period 3 - Nintedanib X mg, BID + HEC585 X mg, QD. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- Subjects aged between 18 and 45 (both inclusive) years old. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female in the first part of the trial) and body mass index ≥19 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram.
Key exclusion criteria (9 listed)
- Subjects with a positive serology for HIV antibodies, HBsAg, HCV antibodies and/or TP antibodies at screening.
- Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, reproductive system; and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions that are not suitable for clinical trial participation.
- Patients with photosensitivity and/or other skin diseases. Bleeding or thrombosis risk. Allergic. Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test. History of alcoholism or drink regularly within 3 months prior to the study. Positive for urine cotinine or smoked within 1 month before administration of study drug in the first part，regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug in the second part.
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 |
|---|---|---|
| HEC585Mulltiple doses of HEC585 for up to 10 days | Drug | HEC585 and Nintedanib, HEC585 and Pirfenidone |
| PirfenidoneMulltiple doses of Pirfenidone for up to 3 days | Drug | HEC585 and Pirfenidone |
| NintedanibMulltiple doses of Nintedanib for up to 7 days | Drug | HEC585 and Nintedanib |
Primary outcome
Cmax of HEC585 and Pirfenidone
Time frame: 0~96 hour
AUC of HEC585 and Pirfenidone
Time frame: 0~96 hour
Cmax of HEC585 and Nintedanib
Time frame: 0~96 hour
AUC of HEC585 and Nintedanib
Time frame: 0~96 hour
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 19 May 2022.
- 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, Pirfenidone and Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma 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 4 inclusion and 9 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 19 May 2022. 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 of HEC585 and Pirfenidone (time frame: 0~96 hour). The study lists 4 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 19 May 2022.