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Recommended Dose Estimation of BP-C2

NCT04186585 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-05-09

No results posted yet for this study

Summary

The aim is to estimate an oral administered recommended dose of BP-C2 in addition to hormone treatment of prostate cancer.

The study population consists of prostatic cancer patients between 18 and 80 years of age undergoing hormonal treatment. Four patients will be recruited consecutively from each of two participating hospital.

The study will be performed as an open, one-dimensional multi-center trial with a 3-level within-patient Response Surface Pathway (RSP) design.

Conditions

Interventions

DRUG

BP-C2

Oral daily intake

Sponsors & Collaborators

  • Meabco A/S

    collaborator INDUSTRY

  • Meddoc

    lead OTHER

Principal Investigators

  • Svein Aa Ingelholm, PhD · Meabco A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-08-01
Completion
2025-09-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

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 NCT04186585 on ClinicalTrials.gov