A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers

Healthy Volunteer Clinical Trial

Official title:

Single-center, Open Label, Multiple Dose Study to Investigate the Pharmacokinetics of RG1662 Given BID Over 28 Days, and in Addition, the Excretion and Metabolism of [13C]-Labelled IV Microdoses and an Oral [14C]-Labelled Dose of RG1662 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684891
• Other study ID #: WP28214
• Secondary ID: 2012-001434-34
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2012
• Last updated: November 1, 2016
• Start date: September 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: De Centrale Commissie Mensgebonden Onderzoek (CCMO)
• Study type: Interventional

Clinical Trial Summary

This is a single-center, open label, multiple dose study to investigate the pharmacokinetics of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male volunteers. The anticipated time of study treatment is 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers

• Volunteers who are surgically sterilized or who do not intend to father children in the future

• 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

• 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

Exclusion Criteria:

• If capable of reproduction, unwilling to use an effective form of contraception

• Suspicion of regular consumption of drug of abuse

• Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2

• Clinically relevant ECG abnormalities at screening

• Family history of congenital long QT syndrome or known congenital arrhythmia

• Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg. Resting Pulse Rate greater than 90 or less than 45 beats per minute

• Any other clinical relevant clinical abnormalities

• Participation in an investigational drug or device study within 90 days prior to screening

• Donation of more than 500 mL of blood within three months prior to 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RG1662
multiple doses of RG1662

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration time curve (AUC)		Selected Days between 1 and 28	No
Primary	Pharmacokinetics: maximum serum concentration		Selected Days between 1 and 28	No
Primary	Pharmacokinetics: Clearance of 13C-RG1662		Days 1 and 28	No
Primary	Pharmacokinetics: Bioavailability of 13C-RG1662		Days 1 and 28	No
Secondary	Amount of drug excreted in urine over the sampling interval		Days 1 to 15	No
Secondary	Amount of drug excreted in the feces over the sampling interval		Pre-dose, days 1 to 15	No
Secondary	Incidence of adverse events		Up to approximately 10 weeks	No