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NCT02775981 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Study of Intranasal RX0041-002 in Hepatic-Impaired Individuals and Subjects With Normal Hepatic Function

A Phase 1 study, sponsored by Pharmaceutical Project Solutions.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT02775981: Completed Phase 1 study, sponsored by Pharmaceutical Project Solutions.

NCT02775981 is a Phase 1 study that has completed, run by Pharmaceutical Project Solutions. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02775981, a Phase 1 study, has completed, sponsored by Pharmaceutical Project Solutions.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the potential effect of hepatic impairment on the systemic pharmacokinetics of RX0041-002 following single dose intranasal administration. The secondary objective is to evaluate the safety and tolerability of intranasal RX0041-002 in subjects with normal hepatic function and hepatic impairment.

Interventions

  • DRUG RX0041-002

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-02
Est. Completion 2016-09
Phase Phase 1
Pharmaceutical Project Solutions

3 total trials

What the finished NCT02775981 record still lists

NCT02775981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which RX0041-002 is the first listed.

NCT02775981 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02775981 about?

NCT02775981 is a clinical study titled "Pharmacokinetic Study of Intranasal RX0041-002 in Hepatic-Impaired Individuals and Subjects With Normal Hepatic Function". The primary objective of this study is to evaluate the potential effect of hepatic impairment on the systemic pharmacokinetics of RX0041-002 following single dose intranasal administration. The secondary objective is to evaluate the safety and tolerability of intranasal RX0041-002 in subjects with n...

What is the current status of trial NCT02775981?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-02. Estimated completion is 2016-09.

What interventions are being tested in trial NCT02775981?

The interventions under investigation include: RX0041-002 (DRUG).

Who is sponsoring clinical trial NCT02775981?

This trial is sponsored by Pharmaceutical Project Solutions, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02775981's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02775981, the US trial registry maintained by the National Library of Medicine. NCT02775981 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.