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Pentoxifylline PKB171 Gel in Healthy Females Volunteers

NCT07017114 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-12

No results posted yet for this study

Summary

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Trial to evaluate the Safety and Tolerability of Pentoxifylline PKB171 Gel in Single-Dose Intravaginal Administration, followed by an Extension Study with Multiple-Dose Administration in Healthy Volunteers. The primary ojective was to determine the maximum tolerated dose (MTD) in terms of local tolerability of PKB171 after single-dose intravaginal administration in healthy female volunteers; the secondary objectives evaluated the safety and tolerability of PKB171 after single-dose intravaginal administration and the pharmacokinetic (PK) profile of PKB171 after single-dose intravaginal administration.

The extension substudy evaluated the safety and tolerability of PKB171 after multiple-dose intravaginal administration at the MTD in healthy volunteers.

Conditions

  • Safety
  • Pharmacokinetics
  • Maximum Tolerated Dose

Interventions

DRUG

Gel PKB171

Subjects received a single dose of pentoxifylline PKB171 gel or placebo, in a one-dose form with an applicator device that allowed for vaginal administration following the randomisation list: * First dose level: 2% (100 mg) * Second dose level: 3% (150 mg) * Third dose level: 4% (200 mg) The treatment was provided by a member of the investigator's staff and self-administered by volunteers under clinical supervision. The dose-escalation process enabled to determine MTD or the highest dose that was safe to administer in later studies was determined. The results of this study helped to define the recommended doses to be used in the multiple-dose extension.

DRUG

Gel PKB171 placebo

PKB vaginal gel at the MTD or placebo once every 24 hours for two consecutive days

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Prokrea BCN, S.L.

    lead INDUSTRY

Principal Investigators

  • José M Palacios, MD · ProkreaBCN, S.L.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2016-04-26
Completion
2016-09-21

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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 NCT07017114 on ClinicalTrials.gov