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Lewy Body DiseasePhase 1NCT04963855

A Phase I Study of GT300 in Healthy Subjects

A Phase 1 study testing GT300 and Microcrystalline cellulose in people with Lewy Body Disease, run by Generian Pharmaceuticals, Inc..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Descriptive safety and pharmacokinetics of GT300, exploratory biomarker effects for the evaluation of the effect of GT300 on the autophagy-lysosomal pathway (ALP), food effect on PK and fasting effect on biomarkers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Lewy Body Disease
What is being tested?
GT300 and Microcrystalline cellulose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
No sites listed yet
Study dates
23 Aug 2021to 15 Mar 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

  • Healthy, adult, male or female (non-lactating) subjects age 18 to 55 inclusive.
  • Good general health, with no significant medical history. Subjects must have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug.
  • Body weight ≥ 50 kg at the screening visit.
  • Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
  • Has laboratory values (clinical chemistry, hematology and coagulation) within the normal reference range. Deviations from this range may be acceptable if they are considered 'not clinically significant' (NCS) by the PI.
  • Women of childbearing potential may be enrolled if one of the following criteria applies:
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  • Must be using an effective form of contraception (e.g., oral contraceptives, vaginal ring, IUD, injected or implanted hormonal contraception) for at least one month prior to study entry, must have maintained a normal menstrual pattern for the three months prior to study entry and have a negative pregnancy test (urine) at the time of admission to the unit. Women must be willing to continue this contraception for 90 days following administration of study drug. Their male partner should use a condom.
  • Is sexually abstinent (Investigator judgement)
  • Is monogamous with a vasectomized (by history; see section 4.2) months prior)
  • Is postmenopausal (i.e., amenorrheic for at least 12 months prior to dosing and demonstrating FSH (follicle-stimulating hormone) consistent with post-menopausal state
  • negative pregnancy test (urine) both at Screening (serum) and Day -1(urine)
  • Is surgically sterilized (confirmed by medical record review)
  • Has had a total hysterectomy a minimum of 3 months prior to dosing on Day 1 (confirmed by medical record review)
  • Males who are sexually abstinent may be enrolled or, if sexually active, may be enrolled if one of the following criteria applies:
  • Has had a vasectomy (>3 months prior to dosing, by history; see section 4.2)
  • Using condoms and whose partner is using an acceptable form of contraception (IUD, oral contraceptives, birth control patch or vaginal ring, injectable or implanted contraceptives, or tubal ligation [surgical sterilization]) from Day -1 to 90 days after study drug administration; using condom with same sex partner
  • Is a light smoker (on average <10 cigarettes/week) or non-smoker and must not have used any nicotine products within one months prior to dosing. Able and willing to attend the necessary visits to the study center.

Who cannot join

  • Blood donation or recipient of blood transfusion in previous 12 weeks.
  • History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Cardiovascular history should include assessment of risk factors for Torsades de Pointes Risk (e.g., heart failure, pulmonary edema, cardiomyopathy, hypokalemia, hypomagnesemia, or hypocalcemia, or family history of Long QT Syndrome, syncope or sudden death).
  • History of neoplastic disease (with the exception of adequately treated non-melanomatous skin carcinoma).
  • Mentally or legally incapacitated (e.g., has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years).
  • Fever (body temperature >38C) or symptomatic viral/bacterial infection or use of antibi-otics within 2 weeks prior to Screening.
  • Resting blood pressure (semi-recumbent) (BP) >140/90 mmHg or heart rate (HR) outside the range 40 to 100 beats per minute at Screening and at Day -1.
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  • Clinically significant abnormality on ECG performed at the Screening Visit or prior to administration of the initial dose of study drug. (Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or bundle branch block.
  • Clinically significant laboratory abnormalities including: Impaired renal function (estimated creatinine clearance (CrCl) of <80 mL/minute based on Creatinine Clearance Value as determined by the clinical chemistry laboratory. Additionally, subjects with elevated unconjugated bilirubin consistent with Gilbert's Syndrome are excluded.
  • Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodefi-ciency virus (HIV) antibody at Screening.
  • Participants with a positive toxicology screening panel (urine test including qualitative identi¬fication of barbiturates, tetrahydrocannabinol, amphetamines, benzodiazepines, opiates, cocaine and cotinine).
  • Participants with a history of substance abuse or dependency or history of recreational IV drug use (by self-declaration).
  • Alcohol consumption >21 alcohol units per week. (One unit of alcohol is 10 ml, information on calculation the content of drinks is provided at: the "alcohol.gov.au" website.
  • Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal remedies (such as St. John's Wort [Hypericum perforatum]), beginning 14 days (or 5 half-lives, whichever is longer) before administration of the initial dose of study drug and continuing throughout the study until the follow-up visit. There may be certain medications that are permitted at the discretion of the Investigator and Sponsor (including paracetamol/acetaminophen, multi-vitamin preparations, medications for the treatment of AEs following administration of study drug and immunizations, in particular any one of the COVID-19 vaccines currently in use in AU).
  • Subjects who are unlikely to comply with the study protocol or, in the opinion of the inves-tigator, would not be a suitable candidate for participation in the study.
  • Have participated in any other investigational drug trial within 30 days of dosing in the present study.

About this study

Official title: A Two-part, Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single Doses of GT300 in Healthy Subjects

Descriptive safety and pharmacokinetics of GT300, exploratory biomarker effects for the evaluation of the effect of GT300 on the autophagy-lysosomal pathway (ALP), food effect on PK and fasting effect on biomarkers.

Read the detailed description

This is a two-part study to be conducted under double-blind conditions. Part A will be conducted first and completed before Parts B is conducted.

Part A is a single ascending dose evaluation of GT300 under double blind conditions in a population of healthy male and female subjects. Part B will be conducted once follow-up of the last cohort Part A has been conducted. On each study day in which drug is administered, dosing will be "staggered". Additionally, during Part A, a "sentinel" group comprising 1 active and 1 placebo subject will be dosed approximately 24 hours prior to dosing the remaining 6 subjects in group 1 (5 active, 1 placebo).

Conduct of the study including clinical evaluation of subjects (up to the safety review meeting) will be under double-blind conditions. Progress from one cohort to the next will be contingent on satisfactory review of the safety and other data from each cohort.

Part B is a single dose evaluation of the effect of food and prolonged fasting on the GT300 PK and biomarkers. The dose of GT300 will be equal to, or less than the maximum dose evaluated in Part A.

Being tested
GT300, Microcrystalline cellulose
Medical subject headings
Lewy Body Disease

What participants receive

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

  • GT300Drug

    SIngle oral dose

  • Microcrystalline celluloseDrug

    placebo

Study groups in NCT04963855
Study groupRoleWhat they receive
CT300Active comparatorGT300 capsule given once daily
Receives: Drug: GT300
PlaceboPlacebo comparatorMicrocrystalline cellulose capsule given once daily
Receives: Drug: Microcrystalline cellulose

What is being measured

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

  1. Pharmacokinetic

    Cmax

    Measured: 8 days

Timeline

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

  1. First posted15 Jul 2021
  2. Study start23 Aug 2021 (estimated)
  3. Primary completion15 Feb 2022 (estimated)
  4. Study completion15 Mar 2022 (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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04963855
Sponsor's protocol ID
GEN-0101
Status last verified
Jun 2021
First submitted
28 Jun 2021
Last updated
15 Jul 2021
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 GT300 and Microcrystalline cellulose in people with Lewy Body Disease, run by Generian Pharmaceuticals, Inc..

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 17 inclusion and 15 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Pharmacokinetic (time frame: 8 days). 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 NCT04963855.

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 15 Jul 2021.

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