A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers

NCT01172847 | Completed Phase 1 Results

• 2 other identifiers: NP227702009-012742-23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This open label, randomized, three-period crossover study will evaluate the effect of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between treatments. Anticipated time on study is up to 11 weeks.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate

  Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5

• Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine

  AUC0-12 of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir, using the linear trapezoidal rule.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5

• Maximum Plasma Concentration (Cmax) of Rimantadine

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5

• Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)

  Up to 11 weeks

• Number of Participants With Abnormal Vital Signs

  Screening (Days -28 to -2); pre-dose and 2h post-dose on D1 and D5 of each treatment period; at Follow-up visit (10 -14 days after last dose) for blood pressure and HR; Screening; Day -1 of each treatment period; Follow-up visit for temperature

• Number of Participants With Marked Abnormality in Laboratory Parameters

  Screening; Day -1 and Day 5 (pre-dose) of each treatment period; Follow-up visit

Study Arms (3)

A

ACTIVE COMPARATOR

Drug: oseltamivir [Tamiflu]

B

ACTIVE COMPARATOR

Drug: rimantadine

C

EXPERIMENTAL

Drug: oseltamivir [Tamiflu]; Drug: rimantadine

Interventions

oseltamivir [Tamiflu] DRUG

multiple oral doses

A; C

rimantadine DRUG

multiple oral doses

B; C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults, aged 18 to 45 years
• Healthy as judged by general physical examination, medical history, vital signs, 12-lead ECG and laboratory tests
• Body Mass Index (BMI) 18-34 kg/m2
• Willing not to participate in any other trial including an investigational drug for 3 months following the last dose
• Male subjects must agree to use a barrier contraception during the study and for 3 months after discontinuation of treatment
• Female subjects of non-child bearing potential or under effective contraception who are either post-menopausal, surgically sterile, or who agree to use barrier contraception during the whole study in addition to an intrauterine device or hormonal contraception for at least 3 months prior to 1st dose, during the study and for 3 months after discontinuation of treatment

You may not qualify if:

• History of or current clinically significant disease or disorder
• Positive Hepatitis B, Hepatitis C, HIV 1 or 2 test result
• Positive pregnancy test or lactating women
• Clinically relevant history of allergy or hypersensitivity
• Clinically relevant history of abuse of alcohol or other drugs; tobacco smoking is allowed (\</= 10 cigarettes a day or equivalent of tobacco in cigars or pipe)
• Any major illness within 30 days prior to screening examination
• Administration of any medication during the 7 days prior to drug administration, except for paracetamol and aspirin (up to 48 hours before first dose) and oral contraceptives
• Participation in a clinical study with an investigational drug within 3 months prior to study day 1
• Donation or loss of more than 500 mL of blood within the 3 months prior to study day 1

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Little Rock, Arkansas, 72204, United States

Location

MeSH Terms

Interventions

Oseltamivir; Rimantadine

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Adamantane; Bridged-Ring Compounds

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: July 30, 2010
• Study Start: August 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 19, 2016
• Results First Posted: March 21, 2016

Record last verified: 2016-01

Locations

US (1)