A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.

Roche

Status and phase: Completed; Phase 1

Conditions: Atherosclerosis

Treatments: Other: LS followed by NS diet condition; Drug: Placebo; Drug: RO6836191; Other: NS followed by LS diet condition

Study type: Interventional

Funder types: Industry

Identifiers

NCT01995383

WP28586

Details and patient eligibility

About

This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.

Enrollment: 88 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers, aged 18 to 45 years old.
• No active or chronic disease following a detailed medical and surgical history and complete physical examination.
• A BMI between 18 to 30 kg/m2 inclusive.
• Use of a highly effective form of birth control for the duration of the study and until 90 days after the last dose.

Exclusion criteria

• Any clinically relevant current or history of conditions or illnesses.
• Clinically significant symptoms of infection within 5 days of the first dosing day or a history of recurrent infections.
• Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse.
• Smokers unable or unwilling to restrict to 5 cigarettes daily during the study and to not smoke during the stay at the clinic.
• Any cardiac abnormalities.
• Blood donation over 450 mL within three months prior to screening.
• Participation in an investigational drug or device study within 3 months prior to dosing.
• Corticosteroid use within 3 months prior to dosing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

88 participants in 6 patient groups, including a placebo group

Part 1: Placebo (PL)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Part 1: Single Ascending Doses (SAD) of RO6836191

Experimental group

Treatment:

Drug: RO6836191

Drug: RO6836191

Drug: RO6836191

Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: RO6836191

Drug: RO6836191

Drug: RO6836191

Other: LS followed by NS diet condition

Part 2: PL: NS followed by LS diet

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: RO6836191

Drug: RO6836191

Other: NS followed by LS diet condition

Drug: RO6836191

Part 2: RO6836191: LS followed by NS diet

Experimental group

Treatment:

Drug: RO6836191

Drug: RO6836191

Drug: RO6836191

Other: LS followed by NS diet condition

Part 2: RO6836191: NS followed by LS diet

Experimental group

Treatment:

Drug: RO6836191

Drug: RO6836191

Other: NS followed by LS diet condition

Drug: RO6836191