Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multi-center, randomized, double-blind, multiple-dose, placebo-controlled, parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized to receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered intravenously twice daily (BID). The anticipated time on study treatment is 5 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir 100 mg | Experimental | Participants will receive 100 mg oseltamivir intravenous BID for 5 days. |
|
| Oseltamivir 200 mg | Experimental | Participants will receive 200 mg oseltamivir intravenous BID for 5 days. |
|
| Placebo | Placebo Comparator | Participants will receive oseltamivir matched placebo intravenous BID for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State | AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5 |
| Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State | Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802 | AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72204 | United States | |||
Not provided
In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received oseltamivir matched placebo twice daily (BID) for 5 days. |
| FG001 | Oseltamivir 100 mg | Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Oseltamivir matched placebo will be administered intravenous for 5 days. |
|
| Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802 |
AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. |
| Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
| Cmax of Oseltamivir and RO0640802 | Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 |
| Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802 | Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
| Half-Life (t1/2) of Oseltamivir and RO0640802 | t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
| Volume of Distribution (Vd) of Oseltamivir and RO0640802 | Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
| Clearance (CL) of Oseltamivir and RO0640802 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
| Minimum Plasma Concentration (Cmin) of RO0640802 | Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5 |
| Austin |
| Texas |
| 78744 |
| United States |
| FG002 | Oseltamivir 200 mg | Participants received 200 mg oseltamivir intravenous BID for 5 days. |
| FG003 | Placebo (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration. |
| FG004 | Oseltamivir 100 mg (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration. |
| FG005 | Oseltamivir 200 mg (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received at least one dose of study drug and have a safety assessment performed after initiation of treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received oseltamivir matched placebo BID for 5 days. |
| BG001 | Oseltamivir 100 mg | Participants received 100 mg oseltamivir intravenous BID for 5 days. |
| BG002 | Oseltamivir 200 mg | Participants received 200 mg oseltamivir intravenous BID for 5 days. |
| BG003 | Placebo (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration. |
| BG004 | Oseltamivir 100 mg (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration. |
| BG005 | Oseltamivir 200 mg (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State | AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | ng*hour/mL | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State | Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802 | AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | ng*hour/mL | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802 | AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | ng*hour/mL | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of Oseltamivir and RO0640802 | Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802 | Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | hour | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Half-Life (t1/2) of Oseltamivir and RO0640802 | t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | hour | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution (Vd) of Oseltamivir and RO0640802 | Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | Liter | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clearance (CL) of Oseltamivir and RO0640802 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | Liters/hour | Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Plasma Concentration (Cmin) of RO0640802 | Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir. | PK analysis population. Only participants who received oseltamivir were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5 |
|
|
Up to 10 days after last dose of study drug (32 days)
In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received oseltamivir matched placebo for 5 days. | 0 | 10 | 7 | 10 | ||
| EG001 | Oseltamivir 100 mg | Participants received 100 mg oseltamivir intravenous BID for 5 days. | 0 | 19 | 17 | 19 | ||
| EG002 | Oseltamivir 200 mg | Participants received 200 mg oseltamivir intravenous BID for 5 days. | 0 | 20 | 20 | 20 | ||
| EG003 | Placebo (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration. | 0 | 10 | 2 | 10 | ||
| EG004 | Oseltamivir 100 mg (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration. | 0 | 20 | 8 | 20 | ||
| EG005 | Oseltamivir 200 mg (Incorrect Infusion Duration) | Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration. | 0 | 20 | 13 | 20 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infusion site induration | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infusion site anaesthesia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infusion site coldness | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infusion site warmth | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vessel puncture site reaction | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vein disorders | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|