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AlopeciaPhase 1NCT04805606

A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843

A Phase 1 study testing CKD-843 A, CKD-843 B and CKD-843-R in people with Alopecia, run by Chong Kun Dang Pharmaceutical 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 Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 Read more about this study

Who is it for?
Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alopecia
What is being tested?
CKD-843 A, CKD-843 B and CKD-843-R
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
30 Apr 2021to 24 Dec 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 19 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Those who aged between 19 to 50 inclusion of man who concerned about androgenic alopecia.
  • Those who has body weight ≥ 50kg.
  • Those who has calculated body mass index(BMI) of 18.5 ≤ ~ < 27.0 kg/m2
  • Body Mass Index, kg/m2= Body weight(kg)/[Height(m)2]
  • Those who consent to proper contraception and do not donate sperm until 6 months after the last administration of investigational product.
  • Those who understanding the detailed description of this clinical trial and voluntarily decide to participate.

Who cannot join

  • Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Hemato-oncology disorder, Cardiovascular disorder or Psychical disorder
  • Those who have history of hypersensitivity to active pharmaceutical ingredient, 5α-reductase inhibitor, tocopherol.
  • Those who have the screening(D-28~D-2) test results written below
  • AST, ALT > 1.25 times higher than upper normal level
  • Total bilirubin > 1.5 times higher than upper normal level
  • eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
Show all 20Show fewer
  • "Positive" or "Reactive" test result of Hepatitis B \& C, HIV, RPR
  • Under 5 min resting condition, systolic blood pressure >150 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
  • Those who have a drug abuse history within one year or positive reaction on urine drug screening test.
  • Those who received following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration and Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
  • Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 30 days before the first administration of investigational product.
  • Those who exceeding smoke consumption criteria or can't stop smoking during hospitalization period.
  • Criteria: Smoke > 10 cigarettes/day
  • Those who exceeding an alcohol and caffeine consumption criteria or can't stop consuming alcohol and caffeine during hospitalization period.
  • Criteria: Caffeine > 5 cups/day, Alcohol > 210 g/week
  • Those who took grapefruit within 7 days before the first administration of investigational product.
  • Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product.
  • Those who donated whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
  • Those who received transfusion within 30 days before the first administration of investigational product.
  • Those who are deemed inappropriate to participate in clinical trial by investigators.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, 120-752

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers

A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843

Read the detailed description

A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers

Conditions
Alopecia
Being tested
CKD-843 A, CKD-843 B, CKD-843-R
Medical subject headings
Alopecia

What participants receive

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

  • CKD-843 ADrug

    Single Dose

  • CKD-843 BDrug

    Single Dose

  • CKD-843-RDrug

    QD, PO

Study groups in NCT04805606
Study groupRoleWhat they receive
Sequence 1ExperimentalCKD-843 A - 27mg, Single Dose
Receives: Drug: CKD-843 A
Sequence 2ExperimentalCKD-843 A - 45mg, Single Dose
Receives: Drug: CKD-843 A
Sequence 3ExperimentalCKD-843 A - 56mg, Single Dose
Receives: Drug: CKD-843 A
Sequence 4ExperimentalCKD-843 B - 45mg, Single Dose
Receives: Drug: CKD-843 B
Sequence 5Active comparatorCKD-843-R
Receives: Drug: CKD-843-R

What is being measured

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

  1. AUClast of CKD-843 A, CKD-843 B

    Area under the concentration-time curve from time zero to last

    Measured: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

  2. AUCinf of CKD-843 A, CKD-843 B

    Area under the concentration-time curve from zero up to ∞

    Measured: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

  3. AUC0-90days of CKD-843 A, CKD-843 B

    Area under the concentration-time curve from time zero to 90 days

    Measured: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

  4. AUClast of CKD-843-R

    Area under the concentration-time curve from time zero to last

    Measured: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

  5. AUCinf of CKD-843-R

    Area under the concentration-time curve from zero up to ∞

    Measured: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

  6. AUC0-90days of CKD-843-R

    Area under the concentration-time curve from time zero to 90 days

    Measured: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

Secondary outcomes (8)

  1. Tmax of CKD-843 A, CKD-843 B

    Time to maximum plasma concentration

    Measured: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

  2. t1/2 of CKD-843 A, CKD-843 B

    Terminal elimination half-life

    Measured: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

  3. CL/F of CKD-843 A, CKD-843 B

    Apparent clearance

    Measured: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

  4. Vd/F of CKD-843 A, CKD-843 B

    Apparent volume of distribution

    Measured: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)

  5. Tmax of CKD-843-R

    Time to maximum plasma concentration

    Measured: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

  6. t1/2 of CKD-843-R

    Terminal elimination half-life

    Measured: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

  7. CL/F of CKD-843-R

    Apparent clearance

    Measured: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

  8. Vd/F of CKD-843-R

    Apparent volume of distribution

    Measured: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)

Timeline

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

  1. First posted18 Mar 2021
  2. Study start30 Apr 2021
  3. Primary completion24 Dec 2021
  4. Study completion24 Dec 2021

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805606
Sponsor's protocol ID
A107_01PK2012
Status last verified
Apr 2022
First submitted
16 Mar 2021
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-843 A, CKD-843 B and CKD-843-R in people with Alopecia, run by Chong Kun Dang Pharmaceutical 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 6 inclusion and 20 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 6 Apr 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 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?

AUClast of CKD-843 A, CKD-843 B (time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)). 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?

On the ClinicalTrials.gov record for NCT04805606.

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 6 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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