Peripheral Neuropathic PainPhase 1NCT03191136
Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers
A Phase 1 study testing YHD1119 300mg in people with Peripheral Neuropathic Pain, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers. Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathic Pain
- What is being tested?
- YHD1119 300mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2017to 30 Oct 2017
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Who cannot join
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Open-label, Randomized, Single Dose, Crossover Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Male Volunteers
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state.
Read the detailed description
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state at Day 1 and in fed state at Day 8.
Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at Day 1 and in fasted state at Day 8.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- YHD1119 300mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHD1119 300mgDrug
Period 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition
YHD1119 300mgDrug
Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | taking YHD1119 (pregabalin 300mg) in fasted state at Period 1 Receives: Drug: YHD1119 300mg |
| Group2 | Experimental | taking YHD1119 (pregabalin 300mg) in fed state at Period 1 Receives: Drug: YHD1119 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
YHD1119 Cmax
Cmax
Measured: 0 - 36hrs
YHD1119 AUC last
AUC last
Measured: 0 - 36hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start10 May 2017
- Primary completion27 Jun 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- Crossover
- Model description
- A randomized, open-label, single dose, cross-over clincial trial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingul Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191136
- Sponsor's protocol ID
- YHD1119-104
- Status last verified
- Jun 2017
- First submitted
- 24 May 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11.
PubMed 34256964
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Randomized, Single Dose, Crossover Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03191136
- Acronym / sponsor ID
- YHD1119-104
- Conditions
- Peripheral Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 May 2017 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 19 Jun 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.
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state.
Detailed description
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state at Day 1 and in fed state at Day 8.
Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at Day 1 and in fasted state at Day 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label, single dose, cross-over clincial trial
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: YHD1119 300mgtaking YHD1119 (pregabalin 300mg) in fasted state at Period 1 |
| Group2 | Experimental | Drug: YHD1119 300mgtaking YHD1119 (pregabalin 300mg) in fed state at Period 1 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Key exclusion criteria (4 listed)
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
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 |
|---|---|---|
| YHD1119 300mgPeriod 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition | Drug | Group1, Group2 |
| YHD1119 300mgPeriod 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition | Drug | Group1, Group2 |
Primary outcome
YHD1119 Cmax
Time frame: 0 - 36hrs
Cmax
YHD1119 AUC last
Time frame: 0 - 36hrs
AUC last
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 16 Jan 2019.
- Derived from this study: PubMed 34256964Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11.
- 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.
Mingul Kim, MD principal investigator
Chonbuk National University Hospital
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 YHD1119 300mg in people with Peripheral Neuropathic Pain, run by Yuhan Corporation at 1 site in South Korea.
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 3 inclusion and 4 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 16 Jan 2019. 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 South Korea. 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?
YHD1119 Cmax (time frame: 0 - 36hrs). The study lists 2 primary outcomes in all. 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 NCT03191136, which also lists 1 linked publication.
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 16 Jan 2019.