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A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02666963
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

Brief Summary:

This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901 following escalating single and multiple oral doses of RTA 901 in healthy adult subjects.

This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD) and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4 will be assessed in each group prior to dose escalation.

Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3 groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 17 will be assessed in each dosing group prior to dose escalation.


Condition or disease Intervention/treatment Phase
Healthy Drug: RTA 901 Capsules, 10 or 40 mg Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 23, 2017
Actual Study Completion Date : July 23, 2017

Arm Intervention/treatment
Experimental: RTA 901 10 mg or 40 mg or Placebo
RTA 901 capsules (10 mg or 40 mg) or placebo taken orally in a single dose. Group 1: RTA 901 10 mg or matching placebo Group 2: RTA 901 20 mg or matching placebo Group 3: RTA 901 ≤ 40 mg or matching placebo Group 4: RTA 901 ≤ 80 mg or matching placebo Group 5: RTA 901 ≤ 160 mg or matching placebo Group 6: RTA 901 ≤ 320 mg or matching placebo Group 7: RTA 901 ≤ 640 mg or matching placebo Dose selection will be based on the safety, tolerability and available pharmacokinetics observed in prior study groups.
Drug: RTA 901 Capsules, 10 or 40 mg
Drug: Placebo
Experimental: RTA 901 Dose TBD or Placebo
RTA 901 capsules, Dose TBD mg or placebo taken orally once daily for 14 days. Group 8: RTA 901 X mg or matching placebo Group 9: RTA 901 ≤Y mg or matching placebo Group 10: RTA 901 ≤Z mg or matching placebo The actual doses for Arm 2 will be selected based on the safety and available pharmacokinetic data obtained from Arm 1.
Drug: RTA 901 Capsules, 10 or 40 mg
Drug: Placebo



Primary Outcome Measures :
  1. Safety and tolerability will be assessed by monitoring adverse events, physical examinations, clinical laboratory tests, 12-lead ECGs, and vital signs [ Time Frame: 14 days ]
    Safety and tolerability will be assessed by monitoring adverse events, physical examinations, clinical laboratory tests, 12-lead ECGs, and vital signs



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female and age is between 18 and 55 years, inclusive.
  • Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding. Non-childbearing potential is defined by at least one of the following criteria:

    1. At least 2 years spontaneous amenorrhea (not attributable to environmental or pathological causes, e.g., anorexia or excessive exercise) with follicle-stimulating hormone (FSH) in post-menopausal range at screening;
    2. At least 3 months post-surgical bilateral oophorectomy or tubal ligation; or
    3. Hysterectomy (must be greater than 5 years post-hysterectomy if due to cancer);
  • Females must have negative results for pregnancy tests performed:

    1. At screening based on a urine specimen obtained within 28 days prior to initial study drug administration, and
    2. Prior to dosing based on a serum sample obtained on Day -1.
  • If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug:

    1. Partner(s) using an IUD;
    2. Partner(s) using hormonal contraceptives (oral, vaginal, parenteral, or transdermal).
    3. Subject and/or partner(s) using double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or creams);
    4. Total abstinence from sexual intercourse as the preferred life style of the subject; periodic abstinence is not acceptable.
  • If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug.
  • Body Mass Index (BMI) is ≥ 18 to < 32 kg/m2, inclusive.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator.
  • Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

  • History of clinically significant drug allergies, including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the investigator; History of clinically significant drug allergies, including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the investigator;
  • Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
  • Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
  • Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis.
  • Use of any medications (over-the-counter and/or prescription medication), vitamins, and/or herbal supplements, within the 30-day period prior to study drug administration or within 5 half-lives (if known), whichever is longer.
  • Recent (6-month) history of drug or alcohol abuse.
  • Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab) at screening.
  • Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.
  • Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to study drug administration.
  • Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1.
  • Consumption of alcohol within 72 hours prior to study drug administration.
  • Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration.
  • Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
  • Current enrollment in another clinical study.
  • Previous enrollment in this study.
  • Screening laboratory analyses that show any of the following abnormal laboratory results:

    1. Alanine transaminase (ALT) level above 1.2× the upper limit of normal (ULN).
    2. Aspartate transaminase (AST) level above 1.2× the ULN.
    3. Any other laboratory results that are outside of the laboratory normal reference range and considered clinically significant by the investigator.
  • Clinically-significant abnormal ECG; ECG with QTc using Fridericia's correction formula (QTcF) > 450 msec is exclusionary.
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive RTA 901.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666963


Locations
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United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.

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Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02666963    
Other Study ID Numbers: RTA 901-C-1503
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Keywords provided by Reata Pharmaceuticals, Inc.:
RTA 901
RTA 901 capsules