Parkinson DiseasePhase 1NCT04513340
WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects
A Phase 1 study testing WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS in people with Parkinson Disease, run by Hong Kong WD Pharmaceutical Co., Limited at 1 site in India.
Trial summary
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics 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 and 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
- 13 Aug 2020to 13 Feb 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.
- 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:
- 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.
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, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine (prescribed \& over the counter (OTC) medication including herbal remedies) at any time within 14 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.
- 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.
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- Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study.
- The presence of clinically significant abnormal laboratory values during screening.
- History or presence of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- 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.
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- A positive test result for HIV (1 \&/or 2) antibody.
- 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.
- Consumption of grapefruit or grapefruit products within 72 hours prior to dosing in period-I.
- Difficulty in swallowing oral solid dosage form like tablets or capsules.
- Nursing mothers (females).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Lambda Therapeutic Research Ltd.
Ahmedabad
Alpesh Jaswantlal Parmar, Doctor, + 91-79-40202020, alpeshjparmar@lambda-cro.com
About this study
Official title: AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics
- Conditions
- Parkinson Disease
- Being tested
- WD-1603 CARBIDOPA and 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 and LEVODOPA EXTENDED-RELEASE TABLETSDrug
CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Treatment A will be given under fed conditions by intra-oral single dose administration Receives: Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS |
| Treatment B | Experimental | Treatment B will be given intra-orally and orally under fed conditions by single dose administration Receives: Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS |
| Treatment C | Experimental | Treatment C will be given orally under fed conditions by single dose administration Receives: Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS |
| Treatment D | Experimental | Treatment D will be given orally under fasting conditions by single dose administration Receives: Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
Measured: Day 1 and Day 2
AUC0-t
Pharmacokinetics Measurements to Determine AUC0-t for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
Measured: Day 1 and Day 2
AUC0-∞
Pharmacokinetics Measurements to Determine AUC0-∞ for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
Measured: Day 1 and Day 2
Secondary outcomes (2)
Tmax
Pharmacokinetics Measurements to Determine Tmax for Carbidopa (CD) and
Measured: Day 1 and Day 2
t1/2
Pharmacokinetics Measurements to Determine t1/2 for Carbidopa (CD) and
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.
- First posted14 Aug 2020
- Study start13 Aug 2020
- Primary completion5 Sep 2020 (estimated)
- Study completion13 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hong Kong WD Pharmaceutical Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513340
- Sponsor's protocol ID
- WD-1603-1002
- Status last verified
- Sep 2020
- First submitted
- 12 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS
- ClinicalTrials.gov ID
- NCT04513340
- Acronym / sponsor ID
- WD-1603-1002
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hong Kong WD Pharmaceutical Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 5 Sep 2020 (estimated)
- Study completion
- 13 Feb 2021 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSTreatment A will be given under fed conditions by intra-oral single dose administration |
| Treatment B | Experimental | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSTreatment B will be given intra-orally and orally under fed conditions by single dose administration |
| Treatment C | Experimental | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSTreatment C will be given orally under fed conditions by single dose administration |
| Treatment D | Experimental | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSTreatment D will be given orally under fasting conditions by single dose administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (19 listed)
- 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, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine (prescribed \& over the counter (OTC) medication including herbal remedies) at any time within 14 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSCARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Cmax
Time frame: Day 1 and Day 2
Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
AUC0-t
Time frame: Day 1 and Day 2
Pharmacokinetics Measurements to Determine AUC0-t for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
AUC0-∞
Time frame: Day 1 and Day 2
Pharmacokinetics Measurements to Determine AUC0-∞ for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations
2 secondary outcomes
Tmax
Time frame: Day 1 and Day 2
t1/2
Time frame: Day 1 and Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WD-1603 CARBIDOPA and 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 8 inclusion and 19 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 10 Sep 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2020.