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GERDPhase 1NCT03558477

PK/PD Clinical Trial of YYD601 in Healthy Adult Male

A Phase 1 study testing YYD601 1, YYD601 2 and YYD601 3 in people with GERD, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site 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

A dose block-randomized, open-label, parallel clinical trial Read more about this study

Who is it for?
Ages 19 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
GERD
What is being tested?
YYD601 1, YYD601 2 and YYD601 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
19 Sep 2017to 7 Feb 2018
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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adult male above 19 years old when getting a screening test.
  • Subjects who have over 50kg weight, included in the IBW± 20% range. [IBW(kg)={height(cm)-100}x0.9
  • Subjects who haven't any congenital or chronic disease, and any other disease following the medical examination.
  • Subjects who are confirmed as a participant by the serum test, hematologital test, blood chemistry tests, urine tests, and clinical laboratory test, 12-lead EKG etc following the characteristics aboht the IP within the 3 weeks before investogator products are administrated.
  • Subjects who voluntarily decide to participated in this trial after comletely understand about this clinical trial.

Who cannot join

  • Subjects who are judged not suitable to participated in this trial.
  • Other specific exlusion criteria is identified in the protocol.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyungpook national university hospital

    Daegu

Other trials in South Korea

About this study

Official title: A Dose Blocked-randomized, Open-label, Parallel Design Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Properties and Safety of YYD601 After Oral Administration in Healthy Adult Male Volunteers(Phase 1)

A dose block-randomized, open-label, parallel clinical trial

Read the detailed description

This study to evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 and Nexium tab and the effects of food influence the PK/PD of YYD601 in healthy adult male.

Conditions
GERD
Being tested
YYD601 1, YYD601 2, YYD601 3, Nexium
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • YYD601 1Drug

    YYD601 1

  • YYD601 2Drug

    YYD601 2

  • YYD601 3Drug

    YYD601 3

  • NexiumDrug

    Nexium

Study groups in NCT03558477
Study groupRoleWhat they receive
Set 1(YYD601 1 & Nexium)ExperimentalSet 1: YYD601 1 \& Nexium
Receives: Drug: YYD601 1; Drug: Nexium
Set 2(YYD601 2 & Nexium)ExperimentalSet 2: YYD601 2 \& Nexium
Receives: Drug: YYD601 2; Drug: Nexium
Set 3(YYD601 3 & Nexium)ExperimentalSet 3:YYD601 3 \& Nexium
Receives: Drug: YYD601 3; Drug: Nexium

What is being measured

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

  1. half-life

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) half-life(after single dose), (after repeated dose)

    Measured: Evaluate the before/after treatment period(5 days per phase)

  2. Tmax

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Tmax(after singlidose), Tmax.ss(after repeated dose)

    Measured: Evaluate the before/after treatment period(5 days per phase)

  3. Concentration

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Cmax(after singlidose), Cmax.ss(after repeated dose) Cmin.ss(after single dose),Cmin.ss(after single dose)

    Measured: Evaluate the before/after treatment period(5 days per phase)

  4. AUC

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) AUClast(after singlidose), AUCt(after repeated dose) AUCinf(after single dose), AUCinf(after repeated dose)

    Measured: Evaluate the before/after treatment period(5 days per phase)

Secondary outcomes (2)

  1. Percent of pH>4 duration time

    pH>4 duration time

    Measured: Evaluate the before/after treatment period(5 days per phase)

  2. % change in serum gastrin level

    serum gastrin level

    Measured: Evaluate the before/after treatment period(5 days per phase)

Timeline

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

  1. First posted15 Jun 2018
  2. Study start19 Sep 2017
  3. Primary completion7 Feb 2018
  4. Study completion7 Feb 2018

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
Model description
Each arm is assignted 10 persons\[the percent of each arm is (treatmnet: comparator=4:1)\]
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03558477
Sponsor's protocol ID
YYPCT_YYD601_P1
Status last verified
Jun 2018
First submitted
11 Oct 2017
Last updated
15 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Yoon YR, Seong SJ. Pharmacokinetics and Pharmacodynamics of YYD601, a Dual Delayed-Release Formulation of Esomeprazole, Following Single and Multiple Doses in Healthy Adult Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2022 Mar 6;16:619-634. doi: 10.2147/DDDT.S338131. eCollection 2022.

    PubMed 35281316

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YYD601 1, YYD601 2 and YYD601 3 in people with GERD, run by Yooyoung Pharmaceutical Co., Ltd. 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 5 inclusion and 2 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 15 Jun 2018. 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?

half-life (time frame: Evaluate the before/after treatment period(5 days per phase)). 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?

On the ClinicalTrials.gov record for NCT03558477, 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 15 Jun 2018.

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