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History of Changes for Study: NCT03815695
A SAD/MAD to Assess the Safety, Pharmacokinetics and Pharmacodynamics of FT-4202 in Adult Healthy Volunteers
Latest version (submitted July 13, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 22, 2019 None (earliest Version on record)
2 March 13, 2019 Arms and Interventions, Eligibility, Outcome Measures, Contacts/Locations, Study Description, Study Status, Study Identification, Study Design and Conditions
3 September 16, 2019 Contacts/Locations and Study Status
4 September 19, 2019 Contacts/Locations and Study Status
5 September 23, 2019 Contacts/Locations and Study Status
6 October 9, 2019 Contacts/Locations and Study Status
7 October 10, 2019 Contacts/Locations and Study Status
8 November 27, 2019 Study Status and Eligibility
9 January 15, 2020 Study Status and Contacts/Locations
10 January 16, 2020 Contacts/Locations and Study Status
11 February 21, 2020 Study Status and Contacts/Locations
12 March 30, 2020 Eligibility, Arms and Interventions, Study Status, Contacts/Locations and Study Design
13 June 15, 2020 Contacts/Locations and Study Status
14 July 15, 2020 Study Status and Contacts/Locations
15 August 19, 2020 Contacts/Locations and Study Status
16 September 1, 2020 Study Status and Contacts/Locations
17 September 18, 2020 Contacts/Locations and Study Status
18 October 15, 2020 Contacts/Locations and Study Status
19 December 22, 2020 Contacts/Locations and Study Status
20 January 6, 2021 Contacts/Locations and Study Status
21 February 11, 2021 Contacts/Locations and Study Status
22 October 19, 2021 Recruitment Status, Study Status and Contacts/Locations
23 December 21, 2021 Recruitment Status, Study Status and Study Design
24 March 31, 2022 Study Status
25 July 13, 2022 Study Status and Study Identification
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Study NCT03815695
Submitted Date:  January 22, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 4202-HVS-101
Brief Title: A SAD/MAD to Assess the Safety, Pharmacokinetics and Pharmacodynamics of FT-4202 in Adult Healthy Volunteers
Official Title: A Randomized, Placebo-controlled, Double Blind, Single Ascending and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of FT-4202 in Adult Healthy Volunteers
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Recruiting
Study Start: December 11, 2018
Primary Completion: December 2019 [Anticipated]
Study Completion: December 2019 [Anticipated]
First Submitted: December 21, 2018
First Submitted that
Met QC Criteria:
January 22, 2019
First Posted: January 24, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
January 22, 2019
Last Update Posted: January 24, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Forma Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators: Medpace, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: FT-4202 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of FT-4202 in the context of Phase 1 studies in adult healthy volunteers. The effects of food on the absorption of FT-4202 will also be evaluated.
Detailed Description: This is a first-in-human (FIH), Phase 1 study of FT-4202 that will characterize the safety, PK and PD of FT-4202 after a single dose and after repeated dosing in healthy adult volunteers. Initially, a dose range of FT-4202 in single ascending dose (SAD) escalation cohorts will be explored in healthy adult subjects. Enrollment of healthy subjects into 2-week multiple ascending dose (MAD) escalation cohorts will be initiated once the safety and PK from at least two SAD cohorts is available to inform the doses for the 2-week MAD portion of the study. Finally, if the safety and PK of the SAD cohorts and initial 2-week MAD cohorts are supportive, an additional single dose cohort is planned to understand food effects (FE) on the PK of FT-4202 in healthy subjects.
Open or close this module Conditions
Conditions: Healthy Volunteers
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Single ascending dose escalation and multiple ascending dose escalation study followed by an evaluation of food effects on absorption
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 98 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Single ascending dose cohorts
Healthy volunteer subject cohorts randomized 6:2 receiving a single dose of FT-4202 or placebo. The first cohort will receive 200 mg of FT-4202 or placebo. Dose escalation will occur if FT-4202 or placebo is tolerated. The maximum dose of FT-4202 or placebo will be 1500 mg.
Drug: FT-4202/Placebo
Healthy volunteer subjects will receive FT-4202/placebo and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies
Experimental: Multiple ascending dose cohorts
Healthy volunteer subject cohorts randomized 9:3 to receive FT-4202 or placebo for 14 days continuous dosing. The first cohort will receive 100 mg of FT-4202 or placebo daily X 14 days. The maximum dose of FT-4202/placebo will be 600 mg FT-4202/placebo daily for 14 days.
Drug: FT-4202/Placebo
Healthy volunteer subjects will receive FT-4202/placebo and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies
Experimental: Food Effect Cohort
Health Volunteer subject cohort of 10 subjects who will receive a single dose of FT-4202 with food and without food. Dose will be administered per the protocol defined dose.
Drug: FT-4202
Healthy volunteer subjects will receive FT-4202 with or without food and undergo pharmacokinetic studies
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence, frequency, and severity of adverse events (AEs) per CTCAE v5.0 of a single ascending dose and multiple ascending doses of FT-4202 in adult healthy volunteers.
[ Time Frame: Up to 3 weeks of monitoring ]

2. Maximum observed plasma concentration (Cmax)
[ Time Frame: Up to 3 weeks of testing ]

3. Time to maximum observed plasma concentration (Tmax)
[ Time Frame: Up to 3 weeks of testing ]

4. Area under the plasma concentration-time curve from time zero until the 24-hour time point (AUC0-24)
[ Time Frame: Up to 3 weeks of testing ]

5. Area under the plasma concentration-time curve from time zero until the last quantifiable time point (AUC0-last)
[ Time Frame: Up to 3 weeks of testing ]

6. Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
[ Time Frame: Up to 3 weeks of testing ]

7. Terminal elimination half-life (t1/2)
[ Time Frame: Up to 3 weeks of testing ]

8. Apparent clearance (CL/F)
[ Time Frame: Up to 3 weeks of testing ]

9. Apparent volume of distribution (Vd/F)
[ Time Frame: Up to 3 weeks of testing ]

10. Terminal disposition rate constant (Lz)
[ Time Frame: Up to 3 weeks of testing ]

11. Renal clearance (ClR)
[ Time Frame: Up to 3 weeks of testing ]

Secondary Outcome Measures:
1. Change from baseline in the levels of 2,3-diphosphoglycerate (DPG) and adenosine triphosphate (ATP) in the red blood cells (RBCs) of healthy adults after single and multiple doses of FT-4202.
[ Time Frame: Up to 3 weeks of testing ]

2. Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax after a single dose of FT-4202 in adult healthy volunteers
[ Time Frame: up to 7 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Subjects must have the ability to understand and sign written informed consent, which must be obtained prior to any study-related procedures being completed
  • Subjects must be in general good health, based upon the results of medical history, a physical examination, vital signs, laboratory profile, and a 12-lead ECG
  • All males and females of child bearing potential must agree to use medically accepted contraceptive regimen during study participation and up to 90 after
  • Subjects must be willing to abide by all study requirements and restrictions

Exclusion Criteria:

  • Evidence of clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study
  • history of clinically significant cardiac diseases including condition disturbances
  • abnormal hematologic, renal and liver function studies history of drug or alcohol abuse
Open or close this module Contacts/Locations
Central Contact Person: Lindsey Wilson
Telephone: 617.679.1970
Email: lwilson@formarx.com
Study Officials: Patrick Kelly, MD
Principal Investigator
Forma Therapeutics, Inc.
Locations: United States, Ohio
Medpace Clinical Pharmacology Unit
[Recruiting]
Cincinnati, Ohio, United States, 45227
Contact:Principal Investigator: Lukasz Biernat, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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