A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants
NCT06670950 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2024-11-01
Summary
Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.
Conditions
- Healthy
Interventions
- DRUG
-
SYT-510
Oral formulation A fasted
- DRUG
-
SYT-510
Oral formulation B fasted
- DRUG
-
SYT-510
Oral formulation A fed
- DRUG
-
Oral formulation
Sponsors & Collaborators
-
Synendos Therapeutics AG
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-10-30
- Primary Completion
- 2025-05-31
- Completion
- 2025-05-31
Countries
- United Kingdom
Study Locations
More Related Trials
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
NCT01971502 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
NCT02666963 ·Status: COMPLETED ·Phase: PHASE1
-
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
NCT01343719 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Relative Bioavailability of Formulations of CKD-510 and to Assess the Effect of Food on the CKD-510 Tablet Formulation in Healthy Subjects
NCT05526742 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
NCT04466514 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants
NCT05099822 ·Status: TERMINATED ·Phase: PHASE1
-
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
NCT04445090 ·Status: TERMINATED ·Phase: PHASE1
-
A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein
NCT03773068 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects
NCT01905553 ·Status: COMPLETED ·Phase: PHASE1
-
Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate
NCT03244462 ·Status: COMPLETED ·Phase: PHASE1
-
BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect
NCT03212586 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
NCT01571570 ·Status: COMPLETED ·Phase: PHASE1
-
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
NCT01951599 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
NCT04801693 ·Status: COMPLETED ·Phase: PHASE1
-
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
NCT02093819 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body
NCT05707403 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults
NCT04310527 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Compare How the Body Absorbs, Distributes and Excretes the Drug Selitrectinib (BAY2731954) Given as Two Different Tablet Formulations or as Liquid Formulations Including the Effect of Food on the Absorption, Distribution or Excretion of the Different Formulations in Healthy Participants
NCT04771390 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
NCT01843972 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants
NCT05195008 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Study to Assess the Influence of Simultaneous CYP3A4 and P-glycoprotein Inhibition on E7080 Pharmacokinetics Following Single Dose Oral Administration of 5 mg E7080 to Healthy Volunteers
NCT02198170 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets
NCT01366352 ·Status: COMPLETED ·Phase: PHASE1
-
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
NCT05029518 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets in Healthy Male and Female Volunteers
NCT02215759 ·Status: COMPLETED ·Phase: PHASE1