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Parkinson DiseasePhase 1NCT04591535

PK Study of WD-1603 in Healthy Subjects

A Phase 1 study testing WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS in people with Parkinson Disease, run by Hong Kong WD Pharmaceutical Co., Limited at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects under fed conditions. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteIndia
Study dates
28 Sep 2020to 28 Mar 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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).
  • Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg / height in m2, a minimum body weight of 50.0 kg.
  • Not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
  • Able to understand and comply with the study procedures, in the opinion of the principal investigator.
  • Able to give voluntary written informed consent for participation in the trial.
  • In case of female subjects:
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  • Surgically sterilized at least 6 months prior to study participation or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
  • And b. Serum Pregnancy test must be negative.
  • g.Female must also be willing to abstain from ovum donation from Screening and for at least 28 days after the last study drug administration.
  • h.Female subjects of non-childbearing potential must be either post-menopausal (post-menopausal is defined as being amenorrheic for at least 1 year without another cause and a follicle-stimulating hormone [FSH] level ≥26 IU/L) or surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
  • i.Male subjects with female sexual partners of childbearing potential must be willing to use and willing to continue using medically acceptable contraception (true abstinence, vasectomy, or male condom for subjects plus an additional method of contraception for their female partners) from dosing until 28 days following the last administration of study drug.
  • j.Men must also be willing to abstain from sperm donation from Screening and for at least 28 days after the last study drug administration.
  • k.Subjects should be literate.

Who cannot join

  • Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug.
  • History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, cardiovascular, immunological, dermatological, gastrointestinal system, and central nervous system with dyskinesia, depression, suicidal thought, or any other body system.
  • History or presence of ophthalmic diseases such as wide angle glaucoma and ocular hypertension.
  • Ingestion of a medicine (prescribed \& over the counter (OTC) medication including herbal remedies and MAO inhibitors) at any time within 30 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
  • Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
  • Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
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  • g.A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period I.
  • h.Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study.
  • i.The presence of clinically significant abnormal laboratory values during screening.
  • j.History or presence of psychiatric disorders. k.A history of difficulty in donating blood. l.Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
  • m.Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication.
  • If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
  • n.A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
  • o.A positive test result for HIV (1 \&/or 2) antibody. p.An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
  • q.Consumption of grapefruit or grapefruit products within 72 hours prior to dosing in period-I.
  • r.Difficulty in swallowing oral solid dosage form like tablets or capsules. s.Nursing mothers (females).

Trial locations and contacts

1 site in 1 country.

Xiaoxiong Wei, Doctor contact

+86-21-6859-9718

xiaoxiong.wei@wdpharma.com

India1 site, 1 recruiting

  • Lambda Therapeutic Research Ltd.

    Ahmedabad

    Alpesh J Parmar, Doctor, + 91-79-40202020, alpeshjparmar@lambda-cro.com

    Recruiting

Other trials in India

About this study

Official title: An Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed Conditions

An open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects under fed conditions. A single oral dose of (either Treatment A or B or C or D) carbidopa/levodopa extended release tablets will be administered to each subject within 5 minutes after completion of standardized vegetarian breakfast under fed condition in each period as per randomization schedule.

Read the detailed description

This is an open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects under fed conditions. A single oral dose of (either Treatment A or B or C or D) carbidopa/levodopa extended release tablets will be administered to each subject within 5 minutes after completion of standardized vegetarian breakfast under fed condition in each period as per randomization schedule.

Being tested
WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
Medical subject headings
Parkinson Disease

What participants receive

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

  • WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETSDrug

    Also called WD-1603

    WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS

Study groups in NCT04591535
Study groupRoleWhat they receive
WD-1603 (tablet strength 1) single doseExperimentalA single oral dose of carbidopa/levodopa extended release tablets (WD-1603 tablet strength 1) will be administered to each subject within 5 minutes at 30 minutes after serving standardized vegetarian breakfast under fed condition in each period as per randomization schedule.
Receives: Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
WD-1603 (tablet strength 2) single doseExperimentalA single oral dose of carbidopa/levodopa extended release tablets (WD-1603 tablet strength 2) will be administered to each subject within 5 minutes at 30 minutes after serving standardized vegetarian breakfast under fed condition in each period as per randomization schedule.
Receives: Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
WD-1603 (tablet strength 3) single doseExperimentalA single oral dose of carbidopa/levodopa extended release tablets (WD-1603 tablet strength 3) will be administered to each subject within 5 minutes at 30 minutes after serving standardized vegetarian breakfast under fed condition in each period as per randomization schedule.
Receives: Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
WD-1603 (tablet strength 4) single doseExperimentalA single oral dose of carbidopa/levodopa extended release tablets (WD-1603 tablet strength 4) will be administered to each subject within 5 minutes at 30 minutes after serving standardized vegetarian breakfast under fed condition in each period as per randomization schedule.
Receives: Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS

What is being measured

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

  1. Cmax

    the maximum plasma concentrations

    Measured: Day 1 and Day 2

  2. AUC

    areas under the plasma concentration

    Measured: Day 1 and Day 2

Timeline

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

  1. First posted19 Oct 2020
  2. Study start28 Sep 2020
  3. Primary completion28 Mar 2021 (estimated)
  4. Study completion28 Mar 2021 (estimated)

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
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04591535
Sponsor's protocol ID
WD-1603-1003
Status last verified
Oct 2020
First submitted
11 Sep 2020
Last updated
19 Oct 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS in people with Parkinson Disease, run by Hong Kong WD Pharmaceutical Co., Limited at 1 site in India.

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 13 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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 India. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaoxiong Wei, Doctor (+86-21-6859-9718, xiaoxiong.wei@wdpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Day 1 and Day 2). 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 NCT04591535.

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 19 Oct 2020.

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