Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects

NCT02118909 | Completed Phase 1

• 1 other identifier: MEI-007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin.

Conditions

Healthy Volunteers; Non-smokers

Outcome Measures

Primary Outcomes (1)

• Peak plasma concentration Cmax in healthy nonsmoking subjects given a single-dose of pracinostat

  Plasma PK parameter Cmax to describe bioavailability of pracinostat

  pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours

Secondary Outcomes (2)

• Number of participants with Adverse Events as a measure of safety and tolerability of single-dose pracinostat when administered with itraconazole or with ciprofloxacin in healthy nonsmoking adult subjects.

  1 month

• Peak plasma PK concentration Area Under the Curve (AUC)AUC 0-t, AUC 0-inf in healthy nonsmoking subjects given a single dose of pracinostat

  pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours

Study Arms (2)

Part 1 (Pracinostat + Itraconazole)

EXPERIMENTAL

Single-dose pracinostat and itraconazole dosing every day for 8 days

Drug: Pracinostat; Drug: Ciprofloxacin

Part 2 (Pracinostat + Ciprofloxacin)

EXPERIMENTAL

Single dose pracinostat and ciprofloxacin 2 times a day for 7 days

Drug: Pracinostat; Drug: Itraconazole

Interventions

Pracinostat DRUG

Part 1 (Pracinostat + Itraconazole); Part 2 (Pracinostat + Ciprofloxacin)

Itraconazole DRUG

Part 2 (Pracinostat + Ciprofloxacin)

Ciprofloxacin DRUG

Part 1 (Pracinostat + Itraconazole)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer
• Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dose
• Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.
• Female subjects must be of non-childbearing potential and must have undergone sterilization procedures at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
• A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication.
• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if:

• Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
• History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
• History or presence of hypersensitivity or idiosyncratic reaction to the study medication or related compounds.
• History of prolonged QT syndrome or require any current medications which may prolong QTc.
• History or presence of:
• myasthenia gravis;
• convulsions.
• Female subjects who are pregnant or lactating.
• Positive urine cotinine, drug and alcohol results at screening or check-in.
• Positive results at screening for HIV, HBsAg or HCV.
• Seated blood pressure is less than 90/40 mgHg or greater than 140/90 mmHg at screening.
• Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
• QTcF interval, is \>430 msec (males) or \>450 msec (females) or deemed clinical abnormal by the PI at screening or prior to dosing.

Sponsors & Collaborators

• Helsinn Healthcare SA: lead

Study Sites (1)

Celerion

Tempe, Arizona, 67296, United States

Location

Related Links

• Sponsor website

MeSH Terms

Interventions

SB939 compound; Itraconazole; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Terry E O'Reilly, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 21, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)