NCT03565861

Brief Summary

This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

May 29, 2018

Last Update Submit

March 11, 2019

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events as a measure of safety and tolerability

    Observed side effects and alteration in laboratory values.

    8 days

Secondary Outcomes (1)

  • Plasma concentration of parent drug

    4 days

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Placebo intravenous 30 minute infusion on day 1

Drug: Placebo

NP10679 5 mg

EXPERIMENTAL

NP10679 5 mg intravenous infusion on day 1

Drug: NP10679

NP10679 15 mg

EXPERIMENTAL

NP10679 15 mg intravenous infusion on day 1

Drug: NP10679

NP10679 50 mg

EXPERIMENTAL

NP10679 50 mg intravenous infusion on day 1

Drug: NP10679

NP10679 100 mg

EXPERIMENTAL

NP10679 100 mg intravenous infusion on day 1

Drug: NP10679

NP10679 200 mg

EXPERIMENTAL

NP10679 200 mg intravenous infusion on day 1

Drug: NP10679

NP10679 300 mg

EXPERIMENTAL

NP10679 300 mg intravenous infusion on day 1

Drug: NP10679

Interventions

PlaceboDRUG

Intravenous vehicle

Placebo
NP10679DRUG

NP10679

NP10679 100 mgNP10679 15 mgNP10679 200 mgNP10679 300 mgNP10679 5 mgNP10679 50 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects aged 18 to 55 years
  • Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
  • If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.

You may not qualify if:

  • Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
  • Recent history (within 2 yrs) or current tobacco use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaron CPC

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Robert Zaczek, Ph.D.

    Neurop Inc.

    STUDY CHAIR

  • Paolo DePetrillo

    Pharmaron CPC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Adaptive design of placebo and up to six escalating doses of NP10679
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 21, 2018

Study Start

April 6, 2018

Primary Completion

September 2, 2018

Study Completion

October 10, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

US(1)