Recruiting NCT07403552
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NSHO-101.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
Overview
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants.
Interventions
- Drug NSHO-101
Dose form - tablet Route of administration - oral Regimen / Treatment period - QD for 14 days
Primary outcome measures
- Pharmacokinetics: Maximum Concentration (Cmax) [Time frame: Day 1 to Day 18]
- Pharmacokinetics: Area Under the Concentration Curve (AUC) [Time frame: Day 1 to Day 18]
- Pharmacokinetics: Trough Concentration (Ctrough) [Time frame: Day 1 to Day 18]
- Pharmacokinetics: Half-life [Time frame: Day 1 to Day 18]
- Pharmacokinetics: Time to Maximum Concentration (tmax) [Time frame: Day 1 to Day 18]
Secondary outcome measures (2)
- Treatment Emergent Adverse Events [Time frame: Day 1 to 14]
- Serious Treatment Emergent Adverse Events [Time frame: Day 1 to Day 14]
Eligibility criteria
Inclusion criteria
- Participants (males and females) at least 18 years of age
- Ability to provide written informed consent
- In good heath as determined by medical evaluation,
- Willing and able to comply with trial restrictions, procedures, and requirements
Exclusion criteria
- Known sensitivity to any components of the IMP
- History of relevant drug hypersensitivity
- Presents or has a history of clinically significant diseases
- History of difficulty swallowing tablets or capsules.
- Any physical examination findings or medical history that might place the participant at an unacceptable risk for participation in this trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Cenexel Anaheim CA — Anaheim
Identifiers
NCT: NCT07403552 · NSHO-101-HV202