Phase 1 Thorough QT Study in Young Healthy Volunteers

NCT00485667 | Completed Phase 1

• 3 other identifiers: SKY0402C105Richmond No. C07027EudraCT Number: 2007-001981-33
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.

Conditions

Postoperative Pain

Keywords

pain; postoperative

Outcome Measures

Primary Outcomes (1)

• ECG findings using the best heart rate correction method

  Up to 96 hours

Secondary Outcomes (1)

• QT/QTc interval data variations from baseline

  up to 96 hours

Study Arms (5)

Moxifloxacin tablet

ACTIVE COMPARATOR

Drug: SKY0402; Drug: Moxifloxacin 400mg; Drug: Placebo injection

Placebo tablet

EXPERIMENTAL

Drug: SKY0402; Drug: Placebo injection; Drug: Placebo tablet

SKY0402 300mg

EXPERIMENTAL

Drug: SKY0402; Drug: Moxifloxacin 400mg; Drug: Placebo tablet

SKY0402 450mg

EXPERIMENTAL

Drug: SKY0402; Drug: Moxifloxacin 400mg; Drug: Placebo tablet

Placebo injection

PLACEBO COMPARATOR

Drug: Moxifloxacin 400mg; Drug: Placebo injection; Drug: Placebo tablet

Interventions

SKY0402 DRUG

Subects received either 300mg or 450mg

Moxifloxacin tablet; Placebo tablet; SKY0402 300mg; SKY0402 450mg

Moxifloxacin 400mg DRUG

Moxifloxacin tablet; Placebo injection; SKY0402 300mg; SKY0402 450mg

Placebo injection DRUG

Moxifloxacin tablet; Placebo injection; Placebo tablet

Placebo tablet DRUG

Placebo injection; Placebo tablet; SKY0402 300mg; SKY0402 450mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult Caucasian men or non-pregnant, non-lactating women between 18 and 40 years of age, inclusive.
• Healthy as judged by responsible physician with no clinically significant abnormality identified on the medical and laboratory evaluation, including 12-lead ECG and vital signs.
• Non-smoker in the previous 3 months.
• Body weight greater than or equal to 50 kg and BMI within the range 19-29 kg/m2, inclusive.
• At screening and Run-in period each ECG should have:
• Consistent sinus rhythm, (i.e. if greater than or equal to 2 ECGs are not sinusal at different time points the volunteer should not be included),
• No clinically significant conduction disorder,
• PR between 120 and 230 ms,
• HR less than or equal to 100 beats/min and greater than or equal to 40 beats/min,
• QRS \< 120 ms,
• QT intervals that can be consistently analysed,
• QTcB less than or equal to 430 ms for males,
• QTcB less than or equal to 450 ms for females
• If there are outlying values in the ECGs, the consistency of these values should be confirmed as follows:
• If HR is between 40 and 44 bpm (inclusive) in 2 ECGs (of one triplicate) on more than one time point during Run-in, subject should not be selected. Conversely, this means that if HR is between 40 and 44 bpm at screening and/or on just one time-point-triplicate during Run-in, the volunteer can be selected.

You may not qualify if:

• History or presence of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
• History of clinically significant syncope.
• Family history of sudden death.
• Family history of premature cardiovascular death.
• Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome.
• History of clinically significant arrhythmias (especially ventricular arrhythmias, atrial fibrillation, or recent conversion from atrial fibrillation).
• Complete bundle branch block / sinus node dysfunction.
• Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
• Any pathology or abnormality with possible influence on the ECGs.
• Clinically significant dermatological disease including history of drug-induced skin rash.
• History of clinically significant psychiatric illness.
• History of gastro-intestinal surgery except appendectomy, herniotomy and cholecystectomy.
• History of chronic inflammation of gastro-intestinal tract.
• History of tendinopathy with fluoroquinolone.
• Subjects with vital signs measurements as follows:

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead
• Richmond Pharmacology Limited: collaborator

Study Sites (1)

Richmond Pharmacology Ltd

London, SW19 0RE, United Kingdom

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jorg Taubel, MD MFPM

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

GB (1)