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Healthy VolunteerPhase 1NCT05012436

A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

A Phase 1 study testing YHD1119 75mg in people with Healthy Volunteer and Renal Impairments, run by Yuhan Corporation at 2 sites in South Korea.

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

The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Read more about this study

Who is it for?
Ages 19 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer, Renal Impairments
What is being tested?
YHD1119 75mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesSouth Korea
Study dates
24 Jul 2021to 10 May 2022
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 19~75 years old, healthy volunteers and renal impairments
  • eGFR >= 60mL/min/1.73m2
  • 60 mL/min/1.73m2 > eGFR >= 30mL/min/1.73m2
  • written informed consent

Who cannot join

  • AST or ALT > 1.5 * Upper normal range
  • Total bilirubin > 1.5 * Upper normal range
  • Blood CPK > 1.5 * Upper normal range
  • Total Cholesterol >1.5 * Upper normal range
  • Woman who is pregnant or lactating
  • Patients who are difficult to participate in cinical trials judged by Investigators
  • have participated in other clinical trials within 180 days before IP intake

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.

Being tested
YHD1119 75mg

What participants receive

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

  • YHD1119 75mgDrug

    Also called YHD1119 150mg NF

    A single oral dose

Study groups in NCT05012436
Study groupRoleWhat they receive
YHD1119 75mg, 150mg NFExperimentalCLcr (mL/min/1.73m2) >= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF
Receives: Drug: YHD1119 75mg
YHD1119 75mgExperimental60 > CLcr (mL/min/1.73m2) >= 30 Period 1 : YHD1119 75 mg Period 2 : NA
Receives: Drug: YHD1119 75mg

What is being measured

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

  1. Cmax

    Measured: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  2. AUClast

    Measured: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Secondary outcomes (5)

  1. AUCinf

    Measured: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  2. Tmax

    Measured: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  3. t1/2

    Measured: 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour

  4. CL/F

    Measured: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  5. V/F

    Measured: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Timeline

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

  1. First posted19 Aug 2021
  2. Study start24 Jul 2021
  3. Primary completion10 May 2022
  4. Study completion10 May 2022

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
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05012436
Sponsor's protocol ID
YHD1119-107
Status last verified
Jun 2022
First submitted
27 Jul 2021
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park M, Choi S, Han S, Shin W, Kim A, Han S, Kim B, Lim Y, Yoo H. Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function. Transl Clin Pharmacol. 2023 Dec;31(4):226-237. doi: 10.12793/tcp.2023.31.e20. Epub 2023 Dec 20.

    PubMed 38197000

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YHD1119 75mg in people with Healthy Volunteer and Renal Impairments, run by Yuhan Corporation at 2 sites 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 4 inclusion and 7 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Cmax (time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour). 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 NCT05012436, 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 30 Jun 2022.

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