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HypogonadismPhase 1NCT04673682

A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-845

A Phase 1 study testing D309 and CKD-845 in people with Hypogonadism, 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 trial to evaluate the pharmacokinetic profiles and safety of CKD-845. Read more about this study

Who is it for?
Ages 19 to 65 years, men only
Conditions the study is for
Hypogonadism
What is being tested?
D309 and CKD-845
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteSouth Korea
Study dates
16 Nov 2020to 7 Jun 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 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult Male over 19 years old and under 65 years old at screening.
  • Serum total testosterone level under 3.0 ng/mL at screening.
  • Subjects who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5 kg/m2 and a total body weight ≥ 55 kg.
  • Body Mass Index(BMI) = Weight(kg) / [Height(m)]2
  • Subjects without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years, except for hypogonadism.
  • Subjects who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.).
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  • Subjects who voluntarily signed an informed consent form approved by the Institutional Review Board(IRB) of each clinical study site and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content of the clinical trial.
  • Subjects who consent to the use of reliable contraception during the clinical trial. Subjects who have no plan of pregnancy and agree to not donate his sperm during the study period and up until 180 days after the last administration of investigational product.
  • Subjects with the ability and willingness to participate during the study period.

Who cannot join

  • Subjects with a medical evidence or a history (excluding a hypogonadism, dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease.
  • 1-1. Subjects with a severe acute/chronic physical and mental conditions that can increase risk or interfere with the interpretation of the results of test.
  • 1-2. Subjects who have a androgen-dependent tumor(e.g., prostate cancer, male breast cancer).
  • 1-3. Subjects with hypercalcemia associated with malignant tumors.
  • 1-4. Subjects with or with a history of liver tumors.
  • 1-5. Subjects with bone metastasis of cancer.
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  • 1-6. Subjects being treated for an enlarged prostate.
  • 1-7. Subjects who have severe alcohol and/or drug abuse history within a year from screening.
  • 1-8. Insulin-dependent diabetes mellitus or uncontrolled non-insulin- dependent diabetes mellitus.
  • Subjects with the following laboratory test results at screening:
  • 2-1. AST, ALT exceeding 2.5 times from the upper limit of normal.
  • 2-2. Total bilirubin exceeding 2.5 times from the upper limit of normal.
  • 2-3. Subjects had renal impairment(eGFR < 60 mL/min/1.73 m2)
  • 2-4. Positive results of virus/bacterial test and/or urine drug test at screening.
  • 2-5. Systolic blood pressure >150 mmHg or <90 mmHg and/or diastolic blood pressure >60 mmHg or >95 mmHg at sitting position.
  • History of regular alcohol consumption exceeding 210 g/week within 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g, 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL of wine (12%) = 12 g).
  • Subjects who smoked more than 20 cigarettes per day within 6 months prior to screening.
  • Subjects who had been administered investigational product(s) from other clinical study or bioequivalence study within 180 days prior to the first dose of this study(except when subject have not taken investigational product(s)).
  • Subjects who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s).
  • Subjects who had taken any contraindication drug(s)(Drug influencing the level of serum testosterone, modulating activity of testosterone and which have drug interaction) within 28 days prior to the first dose of investigational product(s).
  • Subjects who use of oral anticoagulants (with the exception of low-dose aspirin) within 28 days prior to the first dose of investigational product(s).
  • Subjects who use the testosterone pellet within 90 days prior to the first dose of investigational product(s).
  • Subjects who use of any injectable testosterone preparations within 28 days prior to the first dose of investigational product(s).
  • Subjects who use oral testosterone products within 7 days prior to the first dose of investigational product(s).
  • Subjects who use of supplements (e.g., saw palmetto, phytoestrogen, androstenedione, DHEA, niacin, fish oil etc.) prior to the first dose of investigational product(s).
  • Subjects who have hypersensitivity of investigational products and its components.
  • Subjects who donated whole blood within 60 days or blood components within 30 days prior to the first dose of the investigational product(s).
  • Subjects who were deemed inappropriate to participate in the study by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jeonbuk University Hospital

    Jeonju, Jeollabuk-do, 54907

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Single Blind, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety After Administration of CKD-845 in Males

A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-845.

Read the detailed description

A phase 1 clinical trial to evaluate pharmacokinetics and safety in male after administration of CKD-845 and D309.

Conditions
Hypogonadism
Being tested
D309, CKD-845
Keywords
CKD-845
Medical subject headings
Hypogonadism

What participants receive

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

  • D309Drug

    Also called Reference Drug

    D309(Testosterone) 1 vial, Once, IM injection

  • CKD-845Drug

    Also called Test Drug

    CKD-845(Testosterone) 1 vial, Once, IM injection

Study groups in NCT04673682
Study groupRoleWhat they receive
Group 1Experimental1. Treatment A: Reference drug(D309(Testosterone) 1 vial, once, i.m. inj.) 2. Treatment B: Test drug(CKD-845(Testosterone) 1 vial, once, i.m. inj.)
Receives: Drug: D309; Drug: CKD-845
Group 2Experimental1. Treatment B: Test drug(CKD-845(Testosterone) 1 vial, once, i.m. inj.) 2. Treatment A: Reference drug(D309(Testosterone) 1 vial, once, i.m. inj.)
Receives: Drug: D309; Drug: CKD-845

What is being measured

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

  1. Baseline corrected AUCt of CKD-845

    AUCt: Area under the concentration-time curve from time zero to time

    Measured: up to 70 days

  2. Baseline corrected Cmax of CKD-845

    Cmax: Maximum plasma concentration of the drug

    Measured: up to 70 days

Secondary outcomes (3)

  1. Baseline corrected AUCinf of CKD-845

    AUCinf: Area under the concentration-time curve from zero up to infinity

    Measured: up to 70 days

  2. Baseline corrected Tmax of CKD-845

    Tmax: Time to maximum plasma concentration

    Measured: up to 70 days

  3. Baseline corrected t1/2 of CKD-845

    t1/2: Terminal elimination half-life

    Measured: up to 70 days

Timeline

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

  1. First posted17 Dec 2020
  2. Study start16 Nov 2020
  3. Primary completion17 May 2022
  4. Study completion7 Jun 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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673682
Sponsor's protocol ID
A106_01BE2011
Status last verified
Sep 2022
First submitted
6 Nov 2020
Last updated
28 Sep 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 D309 and CKD-845 in people with Hypogonadism, 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 9 inclusion and 28 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 28 Sep 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?

Baseline corrected AUCt of CKD-845 (time frame: up to 70 days). 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 NCT04673682.

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 28 Sep 2022.

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