MalariaPhase 1NCT05206201
A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects
A Phase 1 study testing ZY19489 Capsule in people with Malaria, run by Zydus Lifesciences Limited at 1 site in India.
Trial summary
A Randomized, Double Blind, Parallel, Placebo-Control, Study Of ZY-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects aged between 18-55 years old (Both Inclusive). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- ZY19489 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 25 Aug 2021to 21 Jan 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to 2 weeks following the End of Study visit.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18.5 to 30.0 kg/m2 (Both inclusive). BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in meters.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination and special investigations).
- Screening vital signs:
- Systolic blood pressure (SBP) - 90-140 mmHg, Diastolic blood pressure (DBP) - 60-90 mmHg, Heart rate (HR) 60-90 bpm.
- QTcF ≤450 ms, PR interval ≤220 ms.
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- Female subjects with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) and be willing and able to continue contraception for 90 days after administration of study treatment.
- Male subjects must agree to use adequate contraception methods during the study and be willing and able to continue contraception for 90 days after administration of study treatment.
- Completion of the written informed consent process prior to undertaking any study related procedure.
- Must be willing and able to communicate and participate in the whole study.
Who cannot join
- Haematology, clinical chemistry or urinalysis results at screening that are outside of clinically acceptable laboratory ranges, and are considered clinically significant by the Investigator.
- Participation in any investigational product study within the 12 weeks preceding IMP administration.
- History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or history of anaphylaxis or other severe allergic reactions. Subjects with seasonal allergies/hay fever or allergy to animals or house dust mite that are untreated and asymptomatic can be enrolled in the study based on Investigator's discretion.
- History of convulsion (including intravenous drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not an exclusion criterion.
- Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma (excluding childhood asthma, or mild asthma with preventative asthma medication required less than monthly), epilepsy, or obsessive-compulsive disorder.
- History of malignancy of any organ system treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
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- Subjects with history of schizophrenia, bi-polar disease, psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis.
- Subjects who have received psychiatric medications within 1 year prior to enrolment, or who have been hospitalized within 5 years prior to enrolment for either a psychiatric illness or due to danger to self or others.
- History of more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.
- History of recurrent headache (e.g. tension-type, cluster or migraine) with a frequency of ≥2 episodes per month on average and/or severe enough to require medical therapy, during the 5 years preceding screening.
- Presence of clinically significant infectious disease or fever (e.g. sublingual temperature ≥38.5°C) within the 14 days prior to enrollment.
- Evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise subject safety.
- Significant inter-current disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, gastrointestinal, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis.
- Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. gastrectomy, diarrhoea).
- Blood donation of any volume within 1 month before IMP administration, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to blood bank during the 12 weeks prior to IMP administration.
- Medical requirement for intravenous immunoglobulin or blood transfusions within 3 months prior to enrollment.
- History or presence of alcohol abuse (alcohol consumption more than 40 g/4 units/4 standard drinks per day), or drug habituation, or any prior intravenous usage of an illicit substance in past one year.
- Tobacco use of more than 5 cigarettes or equivalent per day since last one year, and unable to stop smoking for the duration of the clinical unit confinement.
- Female subject who is breastfeeding or currently pregnant or found positive on pregnancy test.
- Interfering substances
- Any vaccination within the last 28 days and planned vaccination till final study visit.
- Any corticosteroids, anti-inflammatory drugs (excluding commonly used over-thecounter anti-inflammatory drugs such as ibuprofen, acetylsalicylic acid, diclofenac), immunomodulators or anticoagulants within the past 3 months. Any subject currently receiving or having previously received immunosuppressive therapy (including systemic steroids, adrenocorticotrophic hormone or inhaled steroids) at a dose or duration potentially associated with hypothalamic-pituitary-adrenal axis suppression within the past year.
- Ingestion of any poppy seeds within the 24 hours prior to screening
- Consumption of beverages or food containing xanthine bases including Red Bull, chocolate, coffee etc. from 48 hours prior to enrollment.
- Unwillingness to abstain from consumption of grapefruit or Seville oranges from 7 days prior to enrollment until the end of study.
- Use of prescription drugs (excluding contraceptives) or non-prescription drugs or herbal supplements (such as St John's Wort), within 14 days or 5 half-lives (whichever is longer) prior to IMP dosing. Limited use of other non-prescription medications or dietary supplements, not believed to affect subject safety or the overall results of the study, may be permitted on a case-by- case basis following approval by the Sponsor in consultation with the Investigator. Subjects are requested to refrain from taking non-approved concomitant medications from recruitment until the conclusion of the study.
- Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or is unable to cooperate because of a language problem or poor mental development.
- Any subject who is the Principal Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
- Any subject without a good peripheral venous access.
- Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
- Positive urine drug test.
- Positive urine alcohol/breath alcohol test.
- The history or presence of any of the following cardiac conditions: known structural cardiac abnormalities; family history of long QT syndrome; cardiac syncope or recurrent, idiopathic syncope; exercise related clinically significant cardiac events.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following (at screening):
- Sinus node dysfunction.
- Complete bundle branch block.
- Abnormal T wave morphology.
- Any other ECG abnormalities in the standard 12-lead ECG in the opinion of the Investigator will interfere with the ECG analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Prospective, Randomized, Double Blind, Parallel, Placebo-Control, Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects
A Randomized, Double Blind, Parallel, Placebo-Control, Study Of ZY-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects aged between 18-55 years old (Both Inclusive).
Read the detailed description
Study will conduct in two parts. In Part 1; single cohort of 8 subjects. Subjects will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be randomized in a ratio of 6:2 to receive single dose of ZY-19489 or placebo orally after an overnight fast of at least 10 hours.
In Part 2: study each cohort containing eight subjects will be given either a ZY19489 capsule or placebo for three consecutive days. Total three cohorts are planned in this study. Dose escalation will be performed for subsequent cohorts.
- Conditions
- Malaria
- Being tested
- ZY19489 Capsule, Placebo Capsule
- Keywords
- Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZY19489 CapsuleDrug
Two part study with single and multiple dose
Placebo CapsuleDrug
Two part study with single and multiple dose
| Study group | Role | What they receive |
|---|---|---|
| ZY19489 Capsule | Experimental | Experimental study drug Receives: Drug: ZY19489 Capsule |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse event of ZY-19489 administered to healthy subjects.
Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0 or higher) system will be used for reporting and grading
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Secondary outcomes (13)
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Cmax
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
To assess the effect of ZY-19489/ZY-20486on the QTc interval (concentration/QTc modelling).
- Difference between baseline corrected QTc following placebo and baseline corrected QTc following ZY-19489
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
AUC0-∞
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Tmax
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
T1/2
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
CL/F
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
VZ/F
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
λ
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
AUC0-24
AUC0-24 after first dose on Day 0 will be calculated with PK samples on Day 01. AUC0-24 after third dose on Day 2 will be calculated with PK samples on Day 03
Measured: For Part 2 : Baseline to Day 30
Accumulation Index
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 2 : Baseline to Day 30
Rac(AUC)
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 2 : Baseline to Day 30
Rac(Cmax)
Estimation of ZY-19489 and its metabolite ZY-20486
Measured: For Part 2 : Baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start25 Aug 2021
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Deven Parmar, MD, Study chair, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206201
- Sponsor's protocol ID
- ZY19489 1001
- Status last verified
- Jul 2021
- First submitted
- 4 Aug 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Prospective, Randomized, Double Blind, Parallel, Placebo-Control, Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects
- ClinicalTrials.gov ID
- NCT05206201
- Acronym / sponsor ID
- ZY19489 1001
- Conditions
- Malaria
- Keywords
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 25 Jan 2022 (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.
A Randomized, Double Blind, Parallel, Placebo-Control, Study Of ZY-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects aged between 18-55 years old (Both Inclusive).
Detailed description
Study will conduct in two parts. In Part 1; single cohort of 8 subjects. Subjects will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be randomized in a ratio of 6:2 to receive single dose of ZY-19489 or placebo orally after an overnight fast of at least 10 hours.
In Part 2: study each cohort containing eight subjects will be given either a ZY19489 capsule or placebo for three consecutive days. Total three cohorts are planned in this study. Dose escalation will be performed for subsequent cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZY19489 Capsule | Experimental | Drug: ZY19489 CapsuleExperimental study drug |
| Placebo | Placebo comparator | Drug: Placebo CapsuleMatching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to 2 weeks following the End of Study visit.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18.5 to 30.0 kg/m2 (Both inclusive). BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in meters.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination and special investigations).
- Screening vital signs:
- Systolic blood pressure (SBP) - 90-140 mmHg, Diastolic blood pressure (DBP) - 60-90 mmHg, Heart rate (HR) 60-90 bpm.
Key exclusion criteria (38 listed)
- Haematology, clinical chemistry or urinalysis results at screening that are outside of clinically acceptable laboratory ranges, and are considered clinically significant by the Investigator.
- Participation in any investigational product study within the 12 weeks preceding IMP administration.
- History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or history of anaphylaxis or other severe allergic reactions. Subjects with seasonal allergies/hay fever or allergy to animals or house dust mite that are untreated and asymptomatic can be enrolled in the study based on Investigator's discretion.
- History of convulsion (including intravenous drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not an exclusion criterion.
- Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma (excluding childhood asthma, or mild asthma with preventative asthma medication required less than monthly), epilepsy, or obsessive-compulsive disorder.
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 |
|---|---|---|
| ZY19489 CapsuleTwo part study with single and multiple dose | Drug | ZY19489 Capsule |
| Placebo CapsuleTwo part study with single and multiple dose | Drug | Placebo |
Primary outcome
Incidence and Severity of Adverse event of ZY-19489 administered to healthy subjects.
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0 or higher) system will be used for reporting and grading
13 secondary outcomes
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Cmax
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
To assess the effect of ZY-19489/ZY-20486on the QTc interval (concentration/QTc modelling).
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
AUC0-∞
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Tmax
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
T1/2
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
CL/F
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
VZ/F
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
λ
Time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
AUC0-24
Time frame: For Part 2 : Baseline to Day 30
Accumulation Index
Time frame: For Part 2 : Baseline to Day 30
Rac(AUC)
Time frame: For Part 2 : Baseline to Day 30
Rac(Cmax)
Time frame: For Part 2 : Baseline to Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Dr Deven Parmar, MD study chair
Zydus Therapeutics Inc.
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 ZY19489 Capsule in people with Malaria, run by Zydus Lifesciences 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 10 inclusion and 38 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 11 Jul 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 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. Some participants in this study may receive a placebo. 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?
Incidence and Severity of Adverse event of ZY-19489 administered to healthy subjects. (time frame: For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30). 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 11 Jul 2022.