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

NCT03668314 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-02-20

No results posted yet for this study

Summary

A three (3) part study to evaluate the safety, tolerability and PK of RDN-929

Conditions

  • Healthy

Interventions

DRUG

RDN-929

Single dose from 2 mg to TBD

DRUG

Placebo oral capsule

Matching placebo Single dose

DRUG

RDN-929 TBD dose

Fed vs fast dose TBD based upon results of previous cohorts

DRUG

RDN-929

Multiple dose based on results of previous cohorts

DRUG

Placebo oral capsule

Matching placebo multiple dose

Sponsors & Collaborators

  • QPS Netherlands B.V.

    collaborator INDUSTRY

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • PI · QPS Holdings LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-04-15
Completion
2019-04-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03668314 on ClinicalTrials.gov