A Phase 1 interventional study of ALXN1840 and Omeprazole in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 1, Interventional, and Basic science
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum.
Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 24 are open to participants now.
Of its 101 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
First submitted after Alexion Pharmaceuticals, Inc. became part of AstraZeneca.
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Exclusion Criteria:
Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Drug: ALXN1840 · Drug: Omeprazole
Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Drug: ALXN1840 · Drug: Omeprazole
Participants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Drug: ALXN1840 · Drug: Omeprazole
Participants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Drug: ALXN1840 · Drug: Omeprazole
Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Drug: ALXN1840 · Drug: Omeprazole
Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Drug: ALXN1840 · Drug: Omeprazole
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
Also known as: WTX101 (formerly), Bis-choline tetrathiomolybdate, Tiomolibdate choline
Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.
Also known as: Prilosec
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)
AUC0-t was calculated by the linear trapezoidal method.
Time frame: Predose (0 hour) up to 192 hours postdose
Maximum Measured Plasma Concentration (Cmax) of Total Mo
Time frame: Predose (0 hour) up to 192 hours postdose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Day 1 through 14 days following final dose (up to Day 43)
| Milestone | Treatment Sequence 1: ABC | Treatment Sequence 2: ACB | Treatment Sequence 3: BAC | Treatment Sequence 4: BCA | Treatment Sequence 5: CAB | Treatment Sequence 6: CBA |
|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 3 |
| Received at least 1 dose of study drug | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
AUC0-t was calculated by the linear trapezoidal method.
| hours*ng/mL | Treatment A: ALXN1840 (Fasted) | Treatment B: Omeprazole + ALXN1840 (Fasted) | Treatment C: Omeprazole + ALXN1840 (Fed) |
|---|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo) | 14531 ± 6886 | 18537 ± 4303 | 14536 ± 3663 |
| ng/mL | Treatment A: ALXN1840 (Fasted) | Treatment B: Omeprazole + ALXN1840 (Fasted) | Treatment C: Omeprazole + ALXN1840 (Fed) |
|---|---|---|---|
| Maximum Measured Plasma Concentration (Cmax) of Total Mo | 330 ± 124 | 401 ± 78.3 | 385 ± 71.3 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
| Participants | Treatment A: ALXN1840 (Fasted) | Treatment B: Omeprazole + ALXN1840 (Fasted) | Treatment C: Omeprazole + ALXN1840 (Fed) |
|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 6 | 5 | 6 |
Collected over Day 1 through 14 days following final dose (up to Day 43). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A: ALXN1840 (Fasted) | — | 0/18 (0%) | 6/18 (33.3%) |
| Treatment B: Omeprazole + ALXN1840 (Fasted) | — | 0/18 (0%) | 5/18 (27.8%) |
| Treatment C: Omeprazole + ALXN1840 (Fed) | — | 0/18 (0%) | 6/18 (33.3%) |
| Event | Treatment A: ALXN1840 (Fasted) | Treatment B: Omeprazole + ALXN1840 (Fasted) | Treatment C: Omeprazole + ALXN1840 (Fed) |
|---|---|---|---|
| HeadacheNervous system disorders | 3/18 | 1/18 | 2/18 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 0/18 | 3/18 | 0/18 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 3/18 | 1/18 | 2/18 |
| Eyelid oedemaEye disorders | 0/18 | 1/18 | 0/18 |
| Abdominal pain lowerGastrointestinal disorders | 1/18 | 0/18 | 0/18 |
| DyspepsiaGastrointestinal disorders | 0/18 | 0/18 | 1/18 |
| GastroenteritisInfections and infestations | 0/18 | 1/18 | 0/18 |
| RhinitisInfections and infestations | 0/18 | 1/18 | 0/18 |
| Superficial injury of eyeInjury, poisoning and procedural complications | 0/18 | 0/18 | 1/18 |
| Haematocrit decreasedInvestigations | 0/18 | 0/18 | 1/18 |
All enrolled participants.
| Age, Continuous(years) | Treatment Sequence 1: ABC | Treatment Sequence 2: ACB | Treatment Sequence 3: BAC | Treatment Sequence 4: BCA | Treatment Sequence 5: CAB | Treatment Sequence 6: CBA | Total |
|---|---|---|---|---|---|---|---|
| Mean | 30.7 ± 4.16 | 31.3 ± 10.21 | 25.7 ± 2.52 | 36.0 ± 14.11 | 35.0 ± 17.69 | 40.0 ± 12.53 | 33.1 ± 10.75 |
| Sex: Female, Male(Participants) | Treatment Sequence 1: ABC | Treatment Sequence 2: ACB | Treatment Sequence 3: BAC | Treatment Sequence 4: BCA | Treatment Sequence 5: CAB | Treatment Sequence 6: CBA | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 3 | 2 | 2 | 1 | 9 |
| Male | 3 | 2 | 0 | 1 | 1 | 2 | 9 |
Ran from Jan 2014 to primary completion in Mar 2014, 2 months.
Results were first posted in Aug 2023, 9 years 4 months after primary completion.
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Studies of the drugs tested here: Tetrathiomolybdate · Omeprazole
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