Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers

A Randomized, Double Blind, Placebo Controlled, Ascending Single and Multiple Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Food Effect Study of RX-10001 in Healthy Volunteers

This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: RX-10001

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands, 9471 GP
    • PRA International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI: 18 - 32 kg/m2, inclusive
• Female subjects: must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal (amenorrhea duration of 12 months)
• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks") and grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
• Medical history without major pathology
• Resting supine blood pressure and pulse rate showing no clinically relevant deviations as judged by the MI
• Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
• All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI
• Willingness to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

• Evidence of clinically relevant pathology
• Mental handicap
• History of relevant drug and/or food allergies
• Regular/routine treatment with non-topical medications within 30 days prior to drug administration
• Use of tobacco products (less than 60 days prior to drug administration)
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
• Use of concomitant medication (including over the counter medication, health supplements, multivitamins and vitamin C, vitamin and omega-3 supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to the first dose. The use of a limited amount of acetaminophen (paracetamol) is permitted on discretion of the MI.
• Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding the start of this study.
• Donation of more than 100 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood in the 10 months preceding the start of this study.
• Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
• Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
• Positive screen on HBsAg
• Positive screen on anti HCV
• Positive screen on anti HIV 1/2
• Illness within 5 days prior to (the first) drug administration
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SAD cohort 1; Single ascending dose (SAD) cohort 1 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The starting dose will be 300 mg. Subsequent doses will be determined by the pk and safety data from previous cohorts.	Drug: RX-10001; RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
EXPERIMENTAL: SAD cohort 2; SAD cohort 2 will participate in three dosing periods separated by 2 weeks. Eight subjects will be enrolled, 6 will receive RX-10001 and 2 will receive vehicle control. The doses to be administered will be determined by the pk and safety data from previous cohorts.	Drug: RX-10001; RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
EXPERIMENTAL: MAD cohort 1; Multiple ascending dose (MAD) cohort 1 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous SAD cohorts.	Drug: RX-10001; RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
EXPERIMENTAL: MAD cohort 2; MAD cohort 2 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort.	Drug: RX-10001; RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
EXPERIMENTAL: MAD cohort 3; MAD cohort 3 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohorts.	Drug: RX-10001; RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
EXPERIMENTAL: MAD cohort 4; MAD cohort 4 will consist of 10 subjects, 8 will receive RX-10001 and 2 will receive vehicle control. The dose of RX-10001 to be administered will depend upon the pk and safety results of the previous cohort.	Drug: RX-10001; RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability following single and multiple ascending oral doses as assessed by adverse events, vital signs, 12-lead ECG, clinical laboratory and physical exam.	1 and 7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the pk and pharmacodynamics after single and multiple ascending doses	1 and 7 days

Collaborators and Investigators

• Sponsor: Resolvyx Pharmaceuticals, Inc
• Investigators: Principal Investigator: Renger Tiessen, MD PhD, PRA Health Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (ESTIMATE): July 17, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2009
• Last Update Submitted That Met QC Criteria: December 1, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Healthy volunteers; Resolvins; RvE1
• Other Study ID Numbers: RX-10001-002