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

NCT03668314 | Completed Phase 1

• 1 other identifier: RDN-929-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Number of subjects with adverse events

  Listing and summary of AE incidence

  Screening to end of study, up to 7 weeks

• Number of subjects with Physical exam findings

  Listing of clinically significant changes in PE findings

  Screening to end of study, up to 7 weeks

• Number of subjects with Clinical safety lab changes

  Listing and change from baseline to end of study

  Screening to end of study, up to 7 weeks

• Number of subjects with Systolic blood pressure changes

  Listing and change from baseline to end of study

  Screening to end of study, up to 7 weeks

• Number of subjects with Heart rate changes

  Listing and change from baseline to end of study

  Screening to end of study, up to 7 weeks

• Number of subjects with 12 Lead ECG changes

  Change in 12-lead ECG parameters from baseline to end of study

  Screening to end of study, up to 7 weeks

• Number of subjects with 3 Lead ECG findings

  Listing of findings

  Predose to 8 hours post dose on Day 1 (Parts 1 and 2) and Days 1 and 12 (Part 3)

• Number of subjects with C-SSRS changes

  Listing of results

  Baseline to end of study (Part 3 only), up to 7 weeks

• Number of subjects with Visual analogue scale changes

  VAS for headache and nausea

  Baseline to end of study for Part 1 and 3, up to 7 weeks

Secondary Outcomes (3)

• Maximum observed plasma concentration, Cmax

  Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)

• Time to reach maximum observed plasma concentration, Tmax

  Predose to 48 hours post first and last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)

• Area Under the plasma concentration time curve, AUC

  Predose to 48 hours post last dose, up to 2 days (Parts 1 and 2) and 2 weeks (Part 3)

Study Arms (5)

Cohort 1:1 - 1:6 RDN-929

EXPERIMENTAL

RDN-929 single dose capsule

Drug: RDN-929

Cohort 1:1 - 1:6 placebo

PLACEBO COMPARATOR

Placebo single dose capsule

Drug: Placebo oral capsule

Cohort 2:1

EXPERIMENTAL

Fed/Fast RDN-929

Drug: RDN-929 TBD dose

Cohort 3:1- 3:4 RDN-929

EXPERIMENTAL

RDN-929 multiple dose capsules once daily for 12 days

Drug: RDN-929

Cohort 3:1- 3:4 placebo

PLACEBO COMPARATOR

placebo multiple dose capsules once daily for 10 days

Drug: Placebo oral capsule

Interventions

RDN-929 DRUG

Single dose from 2 mg to TBD

Cohort 1:1 - 1:6 RDN-929

Placebo oral capsule DRUG

Matching placebo Single dose

Cohort 1:1 - 1:6 placebo

RDN-929 TBD dose DRUG

Fed vs fast dose TBD based upon results of previous cohorts

Cohort 2:1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy as determined by the Investigator, based on a medical evaluation including medical history physical examination, neurological examination, laboratory tests and cardiac monitoring
• Men, age 18-54 years inclusive at Screening (Part 1) or men and postmenopausal or surgically sterile women age 55-80

You may not qualify if:

• 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.
• Acute suicidality or history of suicidal behavior.
• Alanine aminotransferase or aspartate aminotransferase levels greater than 1.5 times the upper limit of normal (ULN) at Screening. One retest is allowed.
• A corrected QT interval measurement corrected according to the Fridericia rule (QTcF) \> 450 msec during controlled rest at screening or between screening and first dose administration, or family history of long QT syndrome.
• Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the Investigator or Medical Monitor, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
• A clinically significant vital signs abnormality at screening or between screening and first dose administration. This includes, but is not limited to, the following, in the supine position: (a) systolic blood pressure \< 90 or \>150 mmHg, (b) diastolic blood pressure \<50 or \> 95 mmHg, or (c) heart rate \< 45 or \>100 beats per minute.

Sponsors & Collaborators

• Alkermes, Inc.: lead
• QPS Netherlands B.V.: collaborator

Study Sites (1)

QPS Netherlands B.V.

Groningen, Netherlands

Location

Study Officials

• PI

  QPS Holdings LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parts 1 and 3 are parallel designs with escalating doses within each part. Part 2 is a FE cross-over study

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 12, 2018
• Study Start: October 10, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

NL (1)