Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

Open-Label Study to Investigate the Mass Balance and Absolute Bioavailability of a Single Oral Dose of [14C]-Labeled RO7049389 or RO7049389 and an Intravenous Micro-Dose of [13C]-Labeled RO7049389 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729309
• Other study ID #: BP41811
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2021
• Est. completion date: June 14, 2021

Study information

• Verified date: July 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Use of > 5 cigarettes or equivalent nicotine-containing product per day prior to screening

Exclusion Criteria for Mass Balance Cohorts

• Regular work with ionizing radiation or radioactive material

• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

• Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a medical trial in the previous year

• History of gastrointestinal (GI) surgery

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [12C] RO7049389
Participants will receive oral [12C] RO7049389.
• [13C] RO7049389
Participants will receive IV [13C] RO7049389.
• [14C] RO7049389
Participants will receive an oral suspension of [14C] RO7049389.

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Dose Excreted in Urine		Up to Day 17
Primary	Percentage of Dose Excreted in Feces		Up to Day 17
Primary	Absolute Oral BA for RO7049389		Up to Day 4
Secondary	Maximum Plasma Concentration (Cmax) of RO7049389		Up to Day 4
Secondary	Area Under the Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUClast) of RO7049389		Up to Day 4
Secondary	Area Under Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of RO7049389		Up to Day 4
Secondary	Time to Maximum Plasma Concentration (Tmax) of RO7049389		Up to Day 4
Secondary	Apparent Clearance (CL/F) of RO7049389		Up to Day 4
Secondary	Clearance (CL) of RO7049389		Up to Day 4
Secondary	Renal Clearance (CLr) of RO7049389		Up to Day 4
Secondary	Amount Excreted in Urine (Ae) of RO7049389		Up to Day 4
Secondary	Half-Life (T1/2) of RO7049389		Up to Day 4
Secondary	Percentage of Participants with Adverse Events (AEs)		Up to Day 29