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Trial record 1 of 1 for:    LYT-100 (deupirfenidone)
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LYT-100 in Healthy Volunteers and BCRL

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ClinicalTrials.gov Identifier: NCT04243837
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : May 11, 2020
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
PureTech

Brief Summary:

Part 1 is a multiple ascending dose trial in healthy volunteers (HV) of LYT-100 to determine safety, tolerability, and pharmacokinetic (PK) profile under fed conditions.

Part 2 is a single dose safety, tolerability, and PK trial in HV of LYT-100 under fasted conditions.

Part 3 is a trial of up to 6-months duration for safety, tolerability, PK, biomarkers and exploratory clinical assessments in breast carcinoma patients with secondary lymphoedema


Condition or disease Intervention/treatment Phase
Breast Cancer Related Lymphoedema Lymphoedema Drug: LYT-100 Other: Matching Placebo Phase 1

Detailed Description:

Part 1: This is a randomised, double-blind, placebo-controlled, multiple ascending dose design to assess the safety, tolerability and PK profile of multiple doses of LYT-100 administered under fed conditions at steady state in healthy participants. Up to 4 dosing cohorts are planned.

Part 2: The dose level immediately below the maximally tolerated dose in Part 1 will be used in Part 2. Following a minimum 7-day washout of the cohort that received this dose, subjects in Part 2 will be administered a single dose of their assigned treatment under fasting conditions to permit a comparison of the rate and extent of absorption of LYT-100 under fasting conditions to the equivalent dose in a prior fed cohort.

Part 3: Once the optimal dose and regimen is determined with or without food, Part 3 will follow with an open-label, single treatment arm to assess the safety, tolerability, PK, biomarkers and effect on exploratory clinical endpoints of LYT-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part 1 consists of 4 cohorts with active treatment or placebo Part 2 consists of 1 cohort with active treatment or placebo Part 3 consists of 1 cohort with active treatment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Part 1 and Part 2 are double-blind during the data collection. Determination for dose escalation maybe made under unblinded conditions by assessors.

Part 3 is open-label.

Primary Purpose: Treatment
Official Title: A Phase 1/1b MAD and Food Effect Study in Healthy Volunteers of Deupirfenidone (LYT-100) Followed by Further Exploration in Patients With BRCL Upper Limb Secondary Lymphoedema
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: LYT-100 in healthy volunteers with Food
LYT-100, multiple ascending
Drug: LYT-100

LYT-100 is a deuterated form of pirfenidone, an orally active small molecule drug.

Cohorts 1 to 4 (HV subjects) will receive multiple ascending doses, starting at 100 mg BID up to 750 mg, with food for 5-days.

Other Name: Deupirfenidone

Placebo Comparator: Placebo in healthy volunteers with Food
Placebo, multiple administrations
Other: Matching Placebo
Inactive capsule(s)

Experimental: LYT-100 in healthy volunteers, Fasted
LYT-100, Dose below MTD for 1 dose
Drug: LYT-100

LYT-100 is a deuterated form of pirfenidone, an orally active small molecule drug.

Cohort 5 (HV subjects) will receive a dose level below MTD, fasting for 1-day.

Other Name: Deupirfenidone

Placebo Comparator: Placebo in healthy volunteers, Fasted
Placebo, for 1 administration
Other: Matching Placebo
Inactive capsule(s)

Experimental: LYT-100 in patients with BCRL
LYT-100 for 6 months, dose and regimen to be determined
Drug: LYT-100

LYT-100 is a deuterated form of pirfenidone, an orally active small molecule drug.

Cohort 6 (patients with BCRL) will receive an optimally tolerated dose BID, with or without food, for up to 6-months.

Other Name: Deupirfenidone




Primary Outcome Measures :
  1. Safety and tolerability: treatment-emergent adverse events (TEAEs) [ Time Frame: 7 days (main time frame) ]
    Evaluate the safety and tolerability of LYT-100 as measured by TEAEs

  2. Use pharmacokinetics to characterize the plasma concentration of LYT-100 [ Time Frame: 7 days (main time frame) ]
    Measure observed concentration of LYT-100 in blood plasma


Secondary Outcome Measures :
  1. Effect of food on the pharmacokinetic profile of LYT-100 based on plasma concentration of LYT-100 [ Time Frame: 2 days (main time frame) ]
    Measure concentration of LYT-100 in blood plasma in fed or fasted subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main Inclusion Criteria:

Part 1 and 2: Healthy Volunteers

  1. Male or female between 18 and 75 years old (inclusive) at the time of screening.
  2. In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator.

Part 3: Patients with BRCL

  1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
  2. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy [FNA]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study.
  3. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening.
  4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study.
  5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline.
  6. Documented evidence of Stage 1 or 2 lymphoedema.
  7. Receiving standard of care compression or agreeable to using care compression, or no compression at all ≥ 4 weeks prior to screening and throughout the study.

Main Exclusion Criteria:

Part 1 and 2: Healthy Volunteers

  1. History or presence of malignancy at screening or baseline, with the exception of adequately treated localised skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
  2. Clinically significant infection within 28 days of the start of dosing, or infections requiring parenteral antibiotics within the 6 months prior to screening.
  3. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the Investigator).
  4. History or presence at screening or baseline of a condition associated with significant immunosuppression

Part 3: Patients with BRCL

  1. Bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e., sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or lymphatic or vascular malformation, determined at screening.
  2. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the PI.
  3. Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis, dermatitis, necrotising fasciitis, or current open wounds or sores in the affected extremity.
  4. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 2 years, determined at screening.
  5. Initiated use of compression or manual lymphatic drainage or other lymphoedema therapies at the start of the study within 4 weeks of the screening visit. Rescreening is allowed following a course of stable compression regimen of > 4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243837


Contacts
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Contact: LuAnn Sabounjian 774-292-9118 ls@puretechhealth.com
Contact: Michael Chen 617-553-9870 mc@puretechhealth.com

Locations
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Australia, Victoria
Nucleus Network VIC Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jason Lickliter, MD         
Sponsors and Collaborators
PureTech
Novotech (Australia) Pty Limited
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Responsible Party: PureTech
ClinicalTrials.gov Identifier: NCT04243837    
Other Study ID Numbers: LYT-100-2020-01
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes