Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers

NCT04729309 | Completed Phase 1 Results

• 1 other identifier: BP41811
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to characterize the mass balance, absolute bioavailability, route and rates of elimination of RO7049839.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Percentage of Dose Excreted in Urine - MB Cohort

  Up to Day 17

• Percentage of Dose Excreted in Feces - MB Cohort

  Up to Day 17

• Percent Total Recovery (Urine + Feces) - MB Cohort

  Up to Day 17

• Absolute Oral BA for RO7049389 - BA Cohort

  Up to Day 4 of Periods 1 and 2

Secondary Outcomes (17)

• Clearance (CL) of RO7049389 - MB Cohort

  Up to Day 17

• Clearance (CL) of RO7049389 - BA Cohort

  Up to Day 4 of Periods 1 and 2

• Half-Life (T1/2) of RO7049389 - MB Cohort

  Up to Day 17

• Half-Life (T1/2) of RO7049389 - BA Cohort

  Up to Day 4 of Periods 1 and 2

• Maximum Plasma Concentration (Cmax) of RO7049389 - MB Cohort

  Up to Day 17

Study Arms (2)

Mass Balance (MB) Cohort

EXPERIMENTAL

Participants will receive oral \[14C\] RO7049389 under fasted conditions, followed by intravenous IV \[13C\] after a two-hour period.

Drug: [13C] RO7049389; Drug: [14C] RO7049389

Absolute Bioavailability (BA) Cohort

EXPERIMENTAL

In Periods 1 and 2, participants will receive oral \[12C\] RO7049389 under fasted conditions, followed by IV \[13C\] RO7049389. There is a minimum 7-day washout between periods.

Drug: [12C] RO7049389; Drug: [13C] RO7049389

Interventions

[12C] RO7049389 DRUG

Participants will receive oral \[12C\] RO7049389.

Absolute Bioavailability (BA) Cohort

[13C] RO7049389 DRUG

Participants will receive IV \[13C\] RO7049389.

Absolute Bioavailability (BA) Cohort; Mass Balance (MB) Cohort

[14C] RO7049389 DRUG

Participants will receive an oral suspension of \[14C\] RO7049389.

Mass Balance (MB) Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian (must have Caucasian parents and grandparents) or East Asian (must have Chinese, Korean, or Japanese parents and grandparents)
• Body mass index between 18 to 30 kg/m\^2 (inclusive) and a weight range of 50 kg to 100 kg (inclusive) at screening
• For women of childbearing potential: agree to use two methods of contraception, with at least one method considered as highly effective during the study and for at least 90 days after the last dose of study drug
• For men: agree to remain abstinent (refrain from heterosexual intercourse) or agree to use contraceptive measures, and agree to refrain from donating sperm during the treatment period and for at least 90 days after the last dose of study drug

You may not qualify if:

• Pregnant or lactating women, and male participants with partners who are pregnant or lactating
• History or symptoms of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, oncologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study treatment; or of interfering with the interpretation of data
• Personal history or family history of congenital long QT interval (QT) syndrome and/or cardiac sudden death
• History of Gilbert syndrome
• Participants who have had significant acute infection, e.g. influenza, local infection, acute gastrointestinal (GI) symptoms, or any other clinically significant illness within two weeks of dose administration
• Any confirmed significant reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies
• Any clinically significant concomitant diseases or conditions that could interfere with the conduct of the study, or in the opinion of the Investigator, would pose an unacceptable risk to the participant in this study
• Taking any herbal medications or substances, supplements (including vitamins), traditional Chinese medicines, prescription medicine, or over-the-counter medications within 14 days of first dosing or within 5 times the elimination half-life of the medication prior to first dosing, whichever is longer
• History of having received any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
• Are currently enrolled in or have participated in any other clinical study involving an investigational product or in any other type of medical research within the last 90 days (or within 5 half-lives of the investigational product, whichever is longer)
• Donation or loss of blood or blood products in excess of 500 mL within 3 months of screening
• Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
• Hepatitis A, B, C, D, or E or HIV infection
• History of drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males \> 21 units per week and in females \> 14 units per week (1 unit = 1/2 pint of beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann - LaRoche

genentech@druginfo.com

1-800-821-8590

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: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 28, 2021
• Study Start: March 31, 2021
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: July 15, 2024
• Results First Posted: July 15, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)