Completed

Pharmacokinetics of RG1662 in Healthy Male Volunteers Over 28 Days

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Study Aim

This study aims to evaluate the absorption, distribution, metabolism, and excretion of RG1662 in healthy male volunteers over a period of 28 days.

What is being tested

Study of RG1662 Drug

Drug
Who is being recruted

From 30 to 55 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 1
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This study focuses on understanding how a drug called RG1662 works in the body. It's specifically looking at healthy male volunteers to see how the drug behaves when taken twice daily over a period of 28 days. The study also wants to learn about how the body processes and eliminates the drug, using special versions of RG1662 that are labeled with harmless substances. The goal is to gather important information about the drug's safety and behavior, which could help in developing better treatment strategies in the future. During the study, participants will take RG1662 twice daily for 4 weeks. Researchers will measure the drug's levels in the blood at different times to understand how it moves through the body. They will also use special versions of RG1662 that are labeled with harmless substances to track how the body processes and eliminates the drug. The study's main outcomes include measuring the drug's maximum concentration in the blood, how long it stays in the body, and how well it's absorbed when taken orally.

NCT01684891
Principal SponsorHoffmann-La Roche
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 30 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
Body mass index (BMI) between 18 and 30 kg/m2 inclusive
Healthy male volunteers
Volunteers and their partners of childbearing potential must use two medically approved methods of contraception (e.g. hormonal contraception, IUD, barrier contraception), one of which must be a barrier method, for the duration of the study and for 3 months after last drug administration
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10 exclusion criteria prevent from participating
Any other clinical relevant clinical abnormalities
Clinically relevant ECG abnormalities at screening
Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the volunteer in this study
Donation of more than 500 mL of blood within three months prior to screening
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Zuidlaren, NetherlandsOpen in Google Maps
CompletedOne Study Center