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COMPLETED Phase 2

Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)

NCT06629402 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG PF614

Study Locations (1)

Kansas

  • Dr. Vince Clinical Research — Overland Park

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2023-10-05
Est. Completion 2023-11-15
Phase Phase 2

Sponsor

Ensysce Biosciences

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06629402

The ClinicalTrials.gov registry entry for NCT06629402 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ensysce Biosciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06629402 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06629402 about?

NCT06629402 is a clinical study titled "Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)". The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).

What is the current status of trial NCT06629402?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2023-10-05. Estimated completion is 2023-11-15.

What conditions does trial NCT06629402 study?

This clinical trial studies the following conditions: Acute Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06629402?

The interventions under investigation include: Placebo (DRUG), PF614 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06629402?

This trial is sponsored by Ensysce Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06629402 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial