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LYT-100 in healthy volunteers for Lymphoedema

Phase 1 & 2
Waitlist Available
Research Sponsored by PureTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test the safety and tolerability of LYT-100 in healthy volunteers and breast cancer patients with secondary lymphoedema. The trial will also look at how well the drug works and how it is absorbed and metabolized by the body.

Eligible Conditions
  • Lymphedema
  • Lymphoedema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability: treatment-emergent adverse events (TEAEs)
Use pharmacokinetics to characterize the plasma concentration of LYT-100
Secondary outcome measures
Effect of food on the pharmacokinetic profile of LYT-100 based on plasma concentration of LYT-100
Efficacy signals of LYT-100

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: LYT-100 in patients with BCRLExperimental Treatment1 Intervention
LYT-100 BID for 6 months
Group II: LYT-100 in healthy volunteers, FedExperimental Treatment1 Intervention
LYT-100, Dose below MTD for 1 dose
Group III: LYT-100 in healthy volunteers, FastedExperimental Treatment1 Intervention
LYT-100, Dose below MTD for 1 dose
Group IV: LYT-100 in healthy volunteersExperimental Treatment1 Intervention
LYT-100, multiple ascending dose
Group V: Placebo in healthy volunteersPlacebo Group1 Intervention
Placebo, multiple administrations
Group VI: Placebo in healthy volunteers, FastedPlacebo Group2 Interventions
Placebo, for 1 administration
Group VII: Placebo in healthy volunteers, FedPlacebo Group2 Interventions
Placebo, for 1 administration
Group VIII: Placebo in patients with BCRLPlacebo Group1 Intervention
Placebo BID for 6 months

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PureTechLead Sponsor
5 Previous Clinical Trials
781 Total Patients Enrolled
Novotech (Australia) Pty LimitedIndustry Sponsor
68 Previous Clinical Trials
7,372 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
LYT-100 in Healthy Volunteers and BCRL
2020. "LYT-100 in Healthy Volunteers and BCRL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04243837.
~10 spots leftby Apr 2025
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