A 28 Day Parallel Group Study to Assess the Effects of RDN-929

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2020-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects

NCT03668314

Healthy

COMPLETED PHASE1

A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects

NCT04680429

Healthy Volunteers

COMPLETED PHASE1

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

NCT06281158

Healthy Volunteers

COMPLETED PHASE1

A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

NCT06034899

Healthy Adult Volunteers

WITHDRAWN PHASE1

A Study to Learn How the Study Medicine PF-07899895 Are Tolerated and Act in the Body of Healthy Adults

NCT06137729

Healthy

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RDN-929

low, medium and high dose of RDN-929 capsules

Group Type EXPERIMENTAL

RDN-929 oral capsule

Intervention Type DRUG

low, medium and high dose

Placebo

Matching placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

matching placebo dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RDN-929 oral capsule

low, medium and high dose

Intervention Type DRUG

Placebo oral capsule

matching placebo dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult males or postmenopausal or surgically sterile females age 55 - 85 years old.
* Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and ECG recording

Exclusion Criteria

* Any history of major psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN)
* A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations
* A clinically significant vital signs abnormality, as judged by the principal investigator

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes